BD Allergy Syringe
Syringe 0.5ML 27GA 3/8IN IB 25 Tray 1000
60manufacturers in China registered for this device type
7catalogue numbers in this listing
14510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (16), Zhejiang (15), Shanghai (11). 12 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Caina Medical Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 20 |
| BQ Plus Medical Co., Ltd. | Songjiang | Shanghai | Contract manufacturer | 13 |
| Medwell Technology Limited | Dongguan | Guangdong | Contract manufacturer | 10 |
| Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd. | Chengdu | Sichuan | Contract manufacturer | 10 |
| Zhejiang Runqiang Medical Instruments Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 9 |
| Wuxi Yushou Medical Appliances Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 8 |
| Pine Moon Electronics Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Shenzhen HYS Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
| Yangzhou Xingwei Medical Technology Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 5 |
| Zhejiang INI Medical Devices Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 4 |
| ShanDong WeiGao Group Medical Polymer Co., Ltd. | Weihai | Shandong | Contract manufacturer | 3 |
| Hantech (Ningbo) Medical Technology Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 3 |
Showing 12 of 60. All 60 manufacturers in China registered for Syringe, Piston
Record
| Listed by | Becton, Dickinson AND Company, United States |
|---|---|
| FDA product code | FMF |
| Device type | Syringe, Piston |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5860 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K110771 |
| Record published | 2016-09-16 |
| Record revised | 2025-11-13 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Room Temperature |
| Packaging | Case of 40, pack or inner pack of 25, case of 5, shelfpack of 100 |
| Sizes | Length 0.375 to 0.5 in; total volume 1 ml |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 305540 | Length 0.5 in | In distribution |
| 305536 | Length 0.5 in | In distribution |
| 305541 | Total Volume 1 ml | In distribution |
| 305539 | Total Volume 1 ml | In distribution |
| 305537 | Total Volume 1 ml | In distribution |
| 305500 | In distribution | |
| 305538 | Total Volume 1 ml | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Yeso med | Wuxi Yushou Medical Appliances Co., Ltd. | 228 |
| Medallion® | Merit Medical Systems, Inc. | 223 |
| Merit Medical® | Merit Medical Systems, Inc. | 192 |
| Monoject | Cardinal Health | 188 |
| Medline | Medline Industries, Inc. | 127 |
| EasyTouch | MHC Medical Products | 122 |
| Medline Industries, Inc. | Medline Industries, Inc. | 99 |
| Arrow | Teleflex Medical LLC | 94 |
| Ceros | Rhino Medical Supply Inc | 92 |
| Enteral Feeding | Medela LLC | 87 |
| Monoject | Cardinal Health 200, LLC | 83 |
| HSW Soft-Ject® | Henke-Sass Wolf, Gmbh. | 80 |
Showing 12 of 913. All products under Syringe, Piston
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K251350 | 2025-07-29 |
| K212499 | 2022-03-09 |
| K203359 | 2021-07-28 |
| K203453 | 2021-01-25 |
| K201234 | 2020-07-15 |
| K190054 | 2019-10-21 |
| K182589 | 2019-03-14 |
| K172670 | 2018-10-23 |
| K162081 | 2016-12-19 |
| K151870 | 2016-07-08 |
| K151766 | 2015-09-02 |
| K121283 | 2012-05-30 |
| K110771 | 2011-05-13 |
| K010890 | 2001-04-19 |
Recalls Naming This Product
10 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 | Closed |
|---|---|---|---|---|---|---|---|
| Mentor Texas LP | 510(k) number | 2026-04-28 | Class II | Process control | A single lot of expired syringes were distributed due to a distribution system control failure. | 1401 syringes | |
| Becton, Dickinson & Co. | 510(k) number | 2016-09-16 | Class II | Process control | BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required. | 22,400 units | 2018-03-20 |
| Becton, Dickinson & Co. | 510(k) number | 2016-09-16 | Class II | Process control | BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required. | 57600 units | 2018-03-20 |
| Becton, Dickinson & Co. | 510(k) number | 2016-09-16 | Class II | Process control | BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required. | 340,000 units | 2018-03-20 |
| Becton, Dickinson & Co. | 510(k) number | 2016-09-16 | Class II | Process control | BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required of 10-6. | 648,000 units | 2018-03-20 |
| Becton, Dickinson & Co. | 510(k) number | 2016-09-16 | Class II | Process control | BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required. | 547,600 units | 2018-03-20 |
| Becton, Dickinson & Co. | 510(k) number | 2016-09-16 | Class II | Process control | BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required. | 1,528,000 units | 2018-03-20 |
| Becton, Dickinson & Co. | 510(k) number | 2016-03-25 | Class II | Error in labeling | BD 10 mL Syringe Luer-Lok Tip with BD PrecisionGlide Needle 21G x 1 (0.8 mm x 25 mm) and Henry Schein 10 mL Single Use Syringe Luer-Lock are being recalled due to possible adulteration and non-conforming manufacturing practices. | 176,000 units | 2017-04-03 |
| Becton, Dickinson & Co. | 510(k) number | 2016-03-25 | Class II | Error in labeling | BD 10 mL Syringe Luer-Lok Tip with BD PrecisionGlide Needle 21G x 1 (0.8 mm x 25 mm) and Henry Schein 10 mL Single Use Syringe Luer-Lock are being recalled due to possible adulteration and non-conforming manufacturing practices. | 811,200 units | 2017-04-03 |
| Becton, Dickinson & Co. | 510(k) number | 2014-12-19 | Class II | Device Design | The stopper of the 10mL BD Luer-Lok syringe is not properly seated in the syringe. | 564,000 units | 2015-12-07 |
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.