Product code FMF
- Device name
- Syringe, Piston
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation number
- 880.5860
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253112 | Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe) | Hlb Lifescience Co., Ltd. | 2026-05-21 |
| K252279 | Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml) | Chirana T.Injecta,A.S. | 2026-04-17 |
| K253068 | Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin Syringe | CMT Health PTE., Ltd. | 2026-02-23 |
| K253769 | Instylla Delivery Kit | Instylla, Inc. | 2025-12-22 |
| K252518 | DuoprossTM Smart Cap (Type I) | Duopross Meditech Corporate | 2025-12-17 |
| K251089 | EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Syringe with Secure Touch® Safety Needle; EXEL Disposable Hypodermic Needle | Exelint International, Co. | 2025-12-12 |
| K250192 | Verisafe Safety Retractable Insulin Syringes | Promisemed Hangzhou Meditech Co., Ltd. | 2025-12-10 |
| K250853 | Merit Syringe | Merit Medical Systems, Inc. | 2025-11-04 |
| K250510 | Sure-Fine Insulin Syringes | Shina Med Corporation | 2025-10-15 |
| K243660 | Monoject™ 1mL Tuberculin Syringe Luer-Lock Tip (1180100777); Monoject™ 3mL Syringe, Luer-Lock Tip (1180300777); Monoject™ 6mL Syringe, Luer-Lock Tip (1180600777); Monoject™ 12mL Syringe, Luer-Lock Tip (1181200777); Monoject™ 20mL Syringe... | Cardinalhealth | 2025-08-22 |
| K251350 | BD Plastipak™ Syringe | Becton, Dickinson and Company | 2025-07-29 |
| K252033 | Profoject™ Disposable Syringe, Profoject™ Disposable Syringe with Needle | CMT Health PTE., Ltd. | 2025-07-25 |
| K250733 | 3DOSE 1ml Syringe | Bimed Teknik Aletler Sanayi & Ticaret A.S. | 2025-07-03 |
| K251648 | GPS Advanced; GPS Advanced Cannula | Prosidyan, Inc. | 2025-06-24 |
| K250262 | GO-PEN® | Go-Pen Aps | 2025-04-24 |
| K243580 | GraftGun Universal Graft Delivery System (GDS) | SurGenTec, LLC | 2025-02-05 |
| K242434 | Insulin Syringes | Chirana T. Injecta | 2024-12-24 |
| K241856 | Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe) | Hlb Lifescience Co., Ltd. | 2024-12-23 |
| K242099 | Sol-M™ Slip Tip Syringe without Needle, Sol-M™ Eccentric Tip Syringe without Needle | Sol-Millennium Medical, Inc. | 2024-10-22 |
| K241821 | Luer Lock Syringe with Safety Needle; Luer Lock Syringe with Exchangeable Needle; Luer Lock Syringe with Blunt Fill Needle | Sol-Millennium Medical, Inc. | 2024-09-20 |
| K231095 | Tamper Evident Cap | International Medical Industries, Inc. | 2024-09-04 |
| K240961 | Disposable Pen Injector Assembly | Wuxi Nest Biotechnology Co., Ltd. | 2024-08-15 |
| K241426 | GPS Advanced; 5 cc GPS Advanced Cannula | Prosidyan, Inc. | 2024-07-10 |
| K233368 | Allograft Delivery Device (OFAC-C) | Bioventus, LLC | 2024-06-25 |
| K240774 | Pen Injector | Wuxi Nest Biotechnology Co., Ltd. | 2024-06-18 |
| K232950 | Sterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile Disposable Syringe with safety needle | Perfect Medical Industry (Vn) Co., Ltd. | 2024-06-12 |
| K234024 | HWJECT Auto-disable syringe | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 2024-03-19 |
| K233794 | Insulin Syringe | Spm Medicare Pvt. , Ltd. | 2024-03-06 |
| K230235 | Medline Luer Lock Syringes | Medline Industries, LP | 2024-02-16 |
| K231558 | SMB Luer lock disposable syringe | Smb Corporation of India | 2024-01-12 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 05391530753944 | FD-1017NS - 1ml PC Syringe - White Plunger | DMC MEDICAL LIMITED | 2026-06-03 |
| 05391530753951 | FD-1018NS - 1ml PC Syringe - Blue Plunger | DMC MEDICAL LIMITED | 2026-06-03 |
| 05391530754217 | FD-1078NS 20ml PC Syringe - White Plunger - Saline Print | DMC MEDICAL LIMITED | 2026-06-03 |
| 05391530754620 | FD-1048NS 10ml PC Syringe Yellow Plunger Lidocaine | DMC MEDICAL LIMITED | 2026-06-03 |
| 05391530754699 | FD-1075NS 10ml PC Syringe Light Blue Plunger Xylocaine | DMC MEDICAL LIMITED | 2026-06-03 |
| 05391530754941 | FD-1180NS 3ml Nugen Syringe Red Plunge | DMC MEDICAL LIMITED | 2026-06-03 |
| 05391530754965 | FD-1162NS 10ml Nugen Syringe Red Plunger | DMC MEDICAL LIMITED | 2026-06-03 |
| 05391530753968 | FD-1019NS - 1ml PC Syringe - Yellow Plunger | DMC MEDICAL LIMITED | 2026-06-02 |
| 05391530754088 | FD-1021NS 3ml PC Syringe White Plunger | DMC MEDICAL LIMITED | 2026-06-02 |
| 05391530754194 | FD-1034NS 20ml PC Syringe Red Plunger | DMC MEDICAL LIMITED | 2026-06-02 |
| 05391530754224 | FD-1033NS 20ml PC Syringe - Yellow Plunger | DMC MEDICAL LIMITED | 2026-06-02 |
| 05391530754231 | FD-1092NS 20ml PC Syringe Heparin Print - Red Plunger | DMC MEDICAL LIMITED | 2026-06-02 |
| 05391530753487 | FD-1113NS - 10ml PC Syringe Contrast Dark Green Plunger | DMC MEDICAL LIMITED | 2026-06-01 |
| 05391530753562 | FD-1049NS - 10ml PC Syringe - Lidocaine Print - Red Plunger | DMC MEDICAL LIMITED | 2026-06-01 |
| 05391530753517 | FD-1051NS - 10ml PC Syringe Purple Plunger - Lidocaine Print | DMC MEDICAL LIMITED | 2026-06-01 |
| 05391530753524 | FD-1043NS - 10ml PC Syringe - Contrast - Yellow Plunger | DMC MEDICAL LIMITED | 2026-06-01 |
| 05391530753531 | FD-1107NS - 30ml PC Syringe - Yellow Plunger | DMC MEDICAL LIMITED | 2026-06-01 |
| 05391530753548 | FD-1026NS - 10ml PC Syringe - White Plunger | DMC MEDICAL LIMITED | 2026-06-01 |
| 05391530753555 | FD-1158NS - 10ml PC Syringe - Heparin/Saline White Plunger | DMC MEDICAL LIMITED | 2026-06-01 |
| 05391530753463 | FD-1031NS - 20ml PC Syringe White Plunger | DMC MEDICAL LIMITED | 2026-06-01 |
| 05391530753456 | FD-1032NS - 20ml PC Syringe Blue Plunger | DMC MEDICAL LIMITED | 2026-06-01 |
| 05391530753579 | FD-1029NS - 10ml PC Syringe Red Plunger | DMC MEDICAL LIMITED | 2026-06-01 |
| 05391530753593 | FD-1054NS - 10ml PC Syringe - Nitro Print - Red Plunger | DMC MEDICAL LIMITED | 2026-06-01 |
| 05391530753609 | FD-1039NS - 10ml PC Syringe - Heparin Print - Red Plunger | DMC MEDICAL LIMITED | 2026-06-01 |
| 05391530753616 | FD-1071NS - 10ml PC Syringe - Purple Plunger | DMC MEDICAL LIMITED | 2026-06-01 |
| 20192253037880 | Monoject | Cardinal Health 200, LLC | 2024-02-28 |
| 10192253033502 | Monoject | Cardinal Health 200, LLC | 2022-10-21 |
| 10887587060781 | ChronOS | Synthes GmbH | 2015-09-14 |
| 10887587060774 | ChronOS | Synthes GmbH | 2015-09-14 |
| 10887587060743 | ChronOS | Synthes GmbH | 2015-09-14 |