BD Insyte Autoguard
Insyte Autoguard Winged PNK 20GA X 1.0IN
12manufacturers in China registered for this device type
37catalogue numbers in this listing
6510(k) clearances naming this product code
Who Else Makes It
Concentrated in Shandong (3), Guangdong (3), Jiangsu (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amsino Medical (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 22 |
| Bioxin Medical Co., Ltd. | Weihai | Shandong | Contract manufacturer | 8 |
| Weihai Jierui Medical Products Co., Ltd. | Weihai | Shandong | Contract manufacturer | 3 |
| Becton Dickinson Medical Devices Co., Ltd. Suzhou | Suzhou | Jiangsu | Contract manufacturer | 2 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Zhejiang Kindly Medical Devices Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 16 |
| Terumo Medical Products (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 7 |
| Shandong Ande Healthcare Apparatus Co., Ltd. | Zibo | Shandong | Manufacturer | 7 |
| Jiangxi Sanxin Medtec Co., Ltd. | Nanchang | Jiangxi | Manufacturer | 6 |
| Haolang Technology (Foshan) Limited Corporation | Foshan | Guangdong | Contract manufacturer | 6 |
| Guangdong Baihe Medical Technology Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 4 |
| Foshan Special Medical Co., Ltd. | Foshan | Guangdong | Manufacturer | 3 |
Record
| Listed by | Becton, Dickinson AND Company, United States |
|---|---|
| FDA product code | FOZ |
| Device type | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5200 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K201075 |
| Record published | 2016-09-16 |
| Record revised | 2026-01-16 (version 7) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Keep dry; Special storage condition: Fragile, handle with care; Special storage condition: Keep away from sunlight |
| Packaging | Case of 4, pack or inner pack of 50, shelfpack of 50 |
| Sizes | Length 0.75 to 1.88 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 381533 | Size = Catheter Gauge = 20 Gauge (G) | In distribution |
| 382612 | Length 0.75 in | In distribution |
| 381547 | Flow Rate = 95 millilitre per minute (mL or ml/min) | In distribution |
| 381434 | Length 1.16 in | In distribution |
| 382533 | Flow Rate = 63 millilitre per minute (mL or ml/min) | In distribution |
| 382554 | Length 1.16 in | In distribution |
| 382512 | Flow Rate = 20 millilitre per minute (mL or ml/min) | In distribution |
| 381444 | Length 1.16 in | In distribution |
| 381557 | Flow Rate = 205 millilitre per minute (mL or ml/min) | In distribution |
| 381454 | Size = Catheter Gauge = 16 Gauge (G) | In distribution |
| 382644 | Flow Rate = 95 millilitre per minute (mL or ml/min) | In distribution |
| 381537 | Flow Rate = 55 millilitre per minute (mL or ml/min) | In distribution |
| 382547 | Length 1.88 in | In distribution |
| 381523 | Length 1 in | In distribution |
| 381423 | Size = Catheter Gauge = 22 Gauge (G) | In distribution |
| 381534 | Size = Catheter Gauge = 20 Gauge (G) | In distribution |
| 382633 | Length 1 in | In distribution |
| 382647 | Length 1.88 in | In distribution |
| 381512 | Size = Catheter Gauge = 24 Gauge (G) | In distribution |
| 381467 | Size = Catheter Gauge = 14 Gauge (G) | In distribution |
| 382544 | Length 1.16 in | In distribution |
| 382557 | Flow Rate = 185 millilitre per minute (mL or ml/min) | In distribution |
| 382637 | Length 1.88 in | In distribution |
| 381457 | Size = Catheter Gauge = 16 Gauge (G) | In distribution |
| 381433 | Length 1 in | In distribution |
| 381544 | Size = Catheter Gauge = 18 Gauge (G) | In distribution |
| 382534 | Length 1.16 in | In distribution |
| 382523 | Flow Rate = 37 millilitre per minute (mL or ml/min) | In distribution |
| 382654 | Length 1.16 in | In distribution |
| 381447 | Size = Catheter Gauge = 18 Gauge (G) | In distribution |
| 381554 | Flow Rate = 220 millilitre per minute (mL or ml/min) | In distribution |
| 382623 | Flow Rate = 37 millilitre per minute (mL or ml/min) | In distribution |
| 381412 | Size = Catheter Gauge = 24 Gauge (G) | In distribution |
| 381437 | Flow Rate = 55 millilitre per minute (mL or ml/min) | In distribution |
| 382657 | Flow Rate = 185 millilitre per minute (mL or ml/min) | In distribution |
| 382634 | Length 1.16 in | In distribution |
| 382537 | Flow Rate = 54 millilitre per minute (mL or ml/min) | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arrow | Teleflex Medical LLC | 2,368 |
| Cook | Cook Incorporated | 250 |
| Cook Spectrum | Cook Incorporated | 225 |
| Jelco | ICU Medical, Inc | 104 |
| Medline | Medline Industries, Inc. | 95 |
| Deltaven Fast Flash | Delta Med SpA | 77 |
| Deltaven | Delta Med SpA | 73 |
| PowerGlide Pro | Bard Access Systems, Inc. | 63 |
| Peripheral Catheter Insertion Kit | Bard Access Systems, Inc. | 62 |
| Able Central Venous Catheter | Guangdong Baihe Medical Technology Co., Ltd. | 62 |
| Curaplex | Bound Tree Medical, LLC | 61 |
| BD Cathena™ Safety IV Catheter | Becton, Dickinson AND Company | 59 |
Showing 12 of 285. All products under Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K200891 | 2021-06-02 |
| K201075 | 2020-12-18 |
| K172506 | 2017-09-17 |
| K172204 | 2017-08-17 |
| K170336 | 2017-03-10 |
| K170283 | 2017-02-28 |
Recalls Naming This Product
11 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 |
|---|---|---|---|---|---|---|
| Becton Dickinson Infusion Therapy Systems Inc. | 510(k) number | 2025-05-21 | Class II | Component design/selection | Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract. | 50 |
| Becton Dickinson Infusion Therapy Systems Inc. | 510(k) number | 2025-05-21 | Class II | Component design/selection | Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract. | 50 |
| Becton Dickinson Infusion Therapy Systems Inc. | 510(k) number | 2025-05-21 | Class II | Component design/selection | Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract. | 50 units |
| Becton Dickinson Infusion Therapy Systems Inc. | 510(k) number | 2025-05-21 | Class II | Component design/selection | Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract. | 50 units |
| Becton Dickinson Infusion Therapy Systems Inc. | 510(k) number | 2025-05-21 | Class II | Component design/selection | Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract. | 50 units |
| Becton Dickinson Infusion Therapy Systems Inc. | 510(k) number | 2025-05-21 | Class II | Component design/selection | Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract. | 50 units |
| Becton Dickinson Infusion Therapy Systems Inc. | 510(k) number | 2025-05-21 | Class II | Component design/selection | Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract. | 50 units |
| Becton Dickinson Infusion Therapy Systems Inc. | 510(k) number | 2025-05-21 | Class II | Component design/selection | Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract. | 50 units |
| Becton Dickinson Infusion Therapy Systems Inc. | 510(k) number | 2025-05-21 | Class II | Component design/selection | Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract. | 50 units |
| Becton Dickinson Infusion Therapy Systems Inc. | 510(k) number | 2024-06-26 | Class II | Process control | Catheters may contain a hole in the catheter tubing, which could result in leakage during the insertion process. | 26,400 units |
| Becton Dickinson Infusion Therapy Systems Inc. | 510(k) number | 2023-10-04 | Class II | Nonconforming Material/Component | Over-the-needle, intravascular catheters may have needles that do not retract properly into the barrel, which could result in contaminated needlestick injury, blood leaking from the insertion site or catheter, and repeat catheter insertion | 528,000 |
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.