SOL-M™ U-100 Insulin Syringe With Fixed Needle
Intended for medical purposes for the manual aspiration of insulin (U-100 Insulin Only), and for the injection of insulin into parts of the body below the surface skin. SOL-M™ 0.5ml Insulin…
Intended for medical purposes for the manual aspiration of insulin (U-100 Insulin Only), and for the injection of insulin into parts of the body below the surface skin. SOL-M™ 0.5ml Insulin Syringe with half unit marking 31G*5/16” PE Bag (10 ea.)
60manufacturers in China registered for this device type
24catalogue numbers in this listing
7510(k) clearances naming this product code
5recalls on this 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 | Sol-Millennium Medical, Inc., United States |
|---|---|
| FDA product code | FMF |
| Device type | Syringe, Piston |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5860 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2016-09-16 |
| Record revised | 2025-05-02 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 10, box of 10, box of 100, case of 8 |
| Sizes | Total volume 0.3 to 1 ml; length 8 to 12.5 mm; needle gauge 25 to 31 G |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1653151B | Total Volume 0.5 ml | In distribution |
| 1612912B | Length 12.5 mm | In distribution |
| 110102010039 | Total Volume 0.3 ml | In distribution |
| 1653012B | Needle Gauge 30 G | In distribution |
| 16330516 | Length 8 mm | In distribution |
| 1633051B | Needle Gauge 30 G | In distribution |
| 110102010042 | Needle Gauge 31 G | In distribution |
| 1653012 | Length 12.5 mm | In distribution |
| 1613151B | Total Volume 1 ml | In distribution |
| 1612512 | Total Volume 1 ml | In distribution |
| 16130516 | Length 8 mm | In distribution |
| 1633012 | Total Volume 0.3 ml | In distribution |
| 1613012 | Length 12.5 mm | In distribution |
| 1613051B | Total Volume 1 ml | In distribution |
| 1652912B | Total Volume 0.5 ml | In distribution |
| 16530516 | Total Volume 0.5 ml | In distribution |
| 1632912 | Length 12.5 mm | In distribution |
| 1633012B | Needle Gauge 30 G | In distribution |
| 1652912 | Length 12.5 mm | In distribution |
| 1633151B | Needle Gauge 31 G | In distribution |
| 1632912B | Total Volume 0.3 ml | In distribution |
| 1612912 | Needle Gauge 29 G | In distribution |
| 1613012B | Total Volume 1 ml | In distribution |
| 110102010044 | Length 8 mm | 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 |
|---|---|
| K252184 | 2026-08-25 |
| K253110 | 2026-06-18 |
| K242099 | 2024-10-22 |
| K241821 | 2024-09-20 |
| K220713 | 2023-05-04 |
| K222744 | 2022-10-11 |
| K153537 | 2016-06-17 |
Recalls
5 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason |
|---|---|---|---|
| 2024-05-09 | Class II | Other | Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use. |
| 2024-05-09 | Class II | Other | Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use. |
| 2024-05-09 | Class II | Other | Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use. |
| 2024-05-09 | Class II | Other | Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use. |
| 2024-05-09 | Class II | Other | Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use. |
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.