Other
KIT Inflation Device Gtwy Y Adapter
24manufacturers in China registered for this device type
6catalogue numbers in this listing
5510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (11), Anhui (6), Zhejiang (4). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Conod Medical Co., Limited | Changshu | Jiangsu | Contract manufacturer | 48 |
| Principle & Will Biotech (Pinghu) Co., Ltd. | Pinghu | Zhejiang | Contract manufacturer | 39 |
| Sino Protection (Hefei) Medical Products Co., Ltd. | Hefei | Anhui | Contract manufacturer | 18 |
| Changzhou Holymed Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 16 |
| Donghai Xingchen NON-Woven Products Co., Ltd. | North Donghai Development Zone, Lianyungang | Jiangsu | Contract manufacturer | 7 |
| Fengyang Jiehong Nonwoven Product Co., Ltd. | Chuzhou | Anhui | Contract manufacturer | 7 |
| 3A Medical Products Co., Ltd. | Liu An | Anhui | Contract manufacturer | 6 |
| Cobes Industries (Jinzhai) Co., Ltd. | Luan | Anhui | Contract manufacturer | 6 |
| Lianyungang Aiyeh Non-woven Products Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 6 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Ningbo Greetmed Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Specification developer | 75 |
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
Showing 12 of 24. All 24 manufacturers in China registered for General Surgery Tray
Record
| Listed by | Medline Industries, Inc., United States |
|---|---|
| FDA product code | LRO |
| Device type | General Surgery Tray |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4370 |
| 510(k) | K213481 |
| Record published | 2024-07-08 |
| Record revised | 2026-03-12 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 5, case of 30, case of 20, case of 15 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DYNJINFLATE2 | In distribution | |
| RW-1023CT | In distribution | |
| DYNJINFLATE3 | In distribution | |
| TP221907-1 | In distribution | |
| P42453 | In distribution | |
| DYNJINFLATE4 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 67,931 |
| Medline Industries, Inc. | Medline Industries, Inc. | 54,362 |
| Avid TruCustom | Avid Medical, Inc. | 13,498 |
| Halyard | Avid Medical, Inc. | 12,802 |
| ACS | American Contract Systems, Inc. | 10,337 |
| SurgiTrack | Owens & Minor Distribution, Inc. | 5,575 |
| Aligned Medical Solutions | Aligned Medical Solutions | 3,490 |
| SurgiTrackSM | Owens & Minor Distribution, Inc. | 3,364 |
| DeRoyal | Deroyal Industries, Inc. | 2,770 |
| Medline | Medline Industries, Inc. | 1,960 |
| Henry Schein | Henry Schein, Inc. | 729 |
| Stradis | Stradis Healthcare | 685 |
Showing 12 of 113. All products under General Surgery Tray
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K213481 | 2022-05-24 |
| K212258 | 2021-12-03 |
| K970286 | 1997-03-10 |
| K962826 | 1996-09-16 |
| K930700 | 1993-07-09 |
Recalls Naming This Product
42 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Medline Industries, LP – Northfield | 510(k) number | 2026-07-31 | Not classified | Under Investigation by firm | Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may lead to contamination of sterile field or patient infection if product is used. | 60 |
| Medline Industries, LP – Northfield | 510(k) number | 2026-07-23 | Not classified | Packaging process control | The kits contain a Retrograde Coronary Sinus Perfusion (RCSP) cannulae that has the potential for a sterile barrier breach. Sterility of the product cannot be assured. If a compromised pouch seal is not identified prior to use and the cannu | 135 units |
| Medline Industries, LP – Northfield | 510(k) number | 2026-07-20 | Class II | Nonconforming Material/Component | Downstream recall – manufacturer recalled specific lots of BD ChloraPrep Clear – 1mL Applicators. Affected product may exhibit an open or incomplete seal on the packaging of the applicator. Use of potentially contaminated applicator may lea | 222,653 total |
| Medline Industries, LP – Northfield | 510(k) number | 2026-07-10 | Class II | Process change control | Kits contain a potentially contaminated component which were recalled by the manufacturer | 663 kits |
| Medline Industries, LP – Northfield | 510(k) number | 2026-07-08 | Class II | Nonconforming Material/Component | Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential out-of-specification levels of endotoxin of the neurosponges. | 246 kits |
| Medline Industries, LP – Northfield | 510(k) number | 2026-06-12 | Class II | Nonconforming Material/Component | The kits contain BD ChloraPrep Clear – 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is co | 434,595 kits |
| Medline Industries, LP – Northfield | 510(k) number | 2026-06-10 | Class II | Under Investigation by firm | Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformities which present risk of sterility breach. Health consequences from use of product include clinically insignificant extension of surgery to f | 163 kits |
| Medline Industries, LP – Northfield | 510(k) number | 2026-06-08 | Class I | Nonconforming Material/Component | The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in Dextrose Injection, USP, which were recalled due to quality issues that could result in drug ineffectiveness. | 52 kits |
| Medline Industries, LP – Northfield | 510(k) number | 2026-06-05 | Class I | Under Investigation by firm | Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochloride in Dextrose Injection, USP. B. Braun Medical Inc. was notified by their supplier, Spectra Medic | 60 kits |
| Medline Industries, LP – Northfield | 510(k) number | 2026-05-28 | Class II | Process change control | Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen d | 9,272 kits |
| Medline Industries, LP – Northfield | 510(k) number | 2026-05-28 | Class II | Under Investigation by firm | Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medtronic has issued a recall of specific production lots of the Covidien Mon-a-Therm general purpose temperature probe-size 9 due to an error in i | 396 kits |
| Medline Industries, LP – Northfield | 510(k) number | 2026-05-21 | Class II | Nonconforming Material/Component | The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing in | 48075 kits |
| Medline Industries, LP – Northfield | 510(k) number | 2026-05-04 | Class II | Nonconforming Material/Component | During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached pr | 123030 units |
| Medline Industries, LP – Northfield | 510(k) number | 2026-04-27 | Class II | Process control | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application. | 49,654 kits total |
| Medline Industries, LP – Northfield | 510(k) number | 2026-04-27 | Class II | Process control | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application. | 49,654 kits total |
| Medline Industries, LP – Northfield | 510(k) number | 2026-04-27 | Class II | Process control | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application. | 49,654 kits total |
| Medline Industries, LP – Northfield | 510(k) number | 2026-04-10 | Class I | Component design/selection | Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complai | 30120 kits |
| Medline Industries, LP – Northfield | 510(k) number | 2026-03-16 | Class II | Under Investigation by firm | On lot of Sterile Circumcision Kits was distributed without the required sterilization process and is therefore not sterile. | 640 kits |
| Medline Industries, LP – Northfield | 510(k) number | 2026-03-16 | Class II | Under Investigation by firm | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Webcol Large Alcohol Prep Pads to be non-sterile following the | 40845 kits |
| Medline Industries, LP – Northfield | 510(k) number | 2026-02-27 | Class II | Component change control | Unapproved design changes to the products outside of the 510(k) clearance. | 270,311 total |
| Medline Industries, LP – Northfield | 510(k) number | 2026-02-27 | Class II | No Marketing Application | Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601. | 113,843 kits |
| Medline Industries, LP – Northfield | 510(k) number | 2026-02-16 | Class II | Under Investigation by firm | Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. Potential consequences associated with detachment of fragmen | 14,379 kits total |
| Medline Industries, LP – Northfield | 510(k) number | 2026-01-08 | Class II | Process control | Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the | 1212 |
| Medline Industries, LP – Northfield | 510(k) number | 2026-01-07 | Class II | Process control | Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have | 207196 units |
| Medline Industries, LP – Northfield | 510(k) number | 2025-12-24 | Class II | Packaging change control | Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators. | 21854 units |
| Medline Industries, LP – Northfield | 510(k) number | 2025-10-10 | Class I | Nonconforming Material/Component | Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120″ expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may resu | 96,406 total units |
| Medline Industries, LP – Northfield | 510(k) number | 2025-09-10 | Class II | Process control | Specific items and lots of Medline Kits may contain Clearlink IV Sets which Baxter recalled due to customer reports of leaking. | 950 units |
| Medline Industries, LP – Northfield | 510(k) number | 2025-08-08 | Class I | Process control | Convenience kits labeled as sterile have not gone through the sterilization process. | 22 units |
| Medline Industries, LP – Northfield | 510(k) number | 2025-07-08 | Class II | Unknown/Undetermined by firm | Affected kits contain recalled Stryker Color Cuff Sterile Disposable Tourniquet Cuffs. Stryker Instruments initiated this recall due to a potential manufacturing defect in which the flange may detach from the bladder at the welded connectio | 1145 |
| Medline Industries, LP – Northfield | 510(k) number | 2025-04-22 | Class I | Nonconforming Material/Component | Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequate welds on specific lots. Perforators with inadequate welds may break or separate. | 1853 total |
| Medline Industries, LP – Northfield | 510(k) number | 2025-02-24 | Class I | Process change control | Specific Medline Kits were manufactured using Intubation ORAL/NASAL Endotracheal Tubes which were subsequently recalled by Smiths Medical. | 1550 units |
| Medline Industries, LP – Northfield | 510(k) number | 2025-02-13 | Class II | Packaging process control | Potential breach in pouch packaging which could lead to loss of sterility. | 2,422 units |
| Medline Industries, LP – Northfield | 510(k) number | 2025-01-09 | Class II | Under Investigation by firm | Kits contain recalled components due to reports of reduced skin barrier wear time. This refers to a shorter duration that a skin barrier can effectively adhere to and protect the skin before it needs to be replaced. | 0 kits |
| Medline Industries, LP – Northfield | 510(k) number | 2024-12-31 | Class I | Process design | The catheter subassembly in the Integrated Arterial Catheter was manufactured with excess material on the catheter hub. | 942 kits |
| Medline Industries, LP – Northfield | 510(k) number | 2024-12-23 | Class II | Process change control | Certain lots Sterile Infusion Catheters which were mislabeled as having a heparin coating were either distributed or manufactured into medical convenience kits and distributed. | 50 units |
| Medline Industries, LP – Northfield | 510(k) number | 2024-11-21 | Class II | Nonconforming Material/Component | Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination. | 65310 units |
| Medline Industries, LP – Northfield | 510(k) number | 2024-11-18 | Class II | Under Investigation by firm | Certain Medline kits were manufactured and distributed with Procedure Masks with SO SOFT Earloops, and SOFT TOUCH II Surgical Masks which were subsequently recalled for not meeting the bioburden testing requirements of EN 14683. | 749 units |
| Medline Industries, LP – Northfield | 510(k) number | 2024-08-28 | Class II | Under Investigation by firm | Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the DLP Vessel Cannulae. During manufacturing of the three listed lot numbers, product for model 30001 was incorrectly labeled as model 30000. | 15 kits |
| Medline Industries, LP – Northfield | 510(k) number | 2024-04-08 | Class II | Under Investigation by firm | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health. | |
| Medline Industries, LP – Northfield | 510(k) number | 2024-04-08 | Class II | Nonconforming Material/Component | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health. | 1,679,067 units in total |
Showing 40 of 42.
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.