FMF · Syringe, Piston
General Hospital · 21 CFR 880.5860 · Class 2
Overview
| Product Code | FMF |
|---|---|
| Device Name | Syringe, Piston |
| Regulation | 21 CFR 880.5860 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
| 3rd-Party Reviewable | Yes |
Identification
A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 749)
Showing 20 most recent of 749 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252279 | Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml) | Chirana T.Injecta,A.S. | Apr 17, 2026 | SESE |
| K253068 | Profoject Insulin Syringes; Profoject Safelock Disposable Insulin Syringe | CMT Health PTE., Ltd. | Feb 23, 2026 | SESE |
| K253769 | Instylla Delivery Kit | Instylla, Inc. | Dec 22, 2025 | SESE |
| K252518 | DuoprossTM Smart Cap (Type I) | Duopross Meditech Corporate | Dec 17, 2025 | SESE |
| K251089 | EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Syringe with Secure Touch® Safety Needle; EXEL Disposable Hypodermic Needle | Exelint International, Co. | Dec 12, 2025 | SESE |
| K250192 | Verisafe Safety Retractable Insulin Syringes | Promisemed Hangzhou Meditech Co., Ltd. | Dec 10, 2025 | SESE |
| K250853 | Merit Syringe | Merit Medical Systems, Inc. | Nov 4, 2025 | SESE |
| K250510 | Sure-Fine Insulin Syringes | Shina Med Corporation | Oct 15, 2025 | SESE |
| 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, Luer-Lock Tip (1182000777); Monoject 35mL Syringe, Luer-Lock Tip (1183500777); Monoject 60mL Syringe, Luer-Lock Tip (1186000777); Monoject 3mL Syringe, Luer-Lock Tip (8881513934); Monoject 6mL Syringe , Luer-Lock Tip (8881516937); Monojec | Cardinalhealth | Aug 22, 2025 | SESE |
| K251350 | BD Plastipak Syringe | Becton, Dickinson and Company | Jul 29, 2025 | SESE |
| K252033 | Profoject Disposable Syringe, Profoject Disposable Syringe with Needle | CMT Health PTE., Ltd. | Jul 25, 2025 | SESE |
| K250733 | 3DOSE 1ml Syringe | Bimed Teknik Aletler Sanayi & Ticaret A.S. | Jul 3, 2025 | SESE |
| K251648 | GPS Advanced; GPS Advanced Cannula | Prosidyan, Inc. | Jun 24, 2025 | SESE |
| K250262 | GO-PEN® | Go-Pen Aps | Apr 24, 2025 | SESE |
| K243580 | GraftGun Universal Graft Delivery System (GDS) | SurGenTec, LLC | Feb 5, 2025 | SESE |
| K242434 | Insulin Syringes | Chirana T. Injecta | Dec 24, 2024 | SESE |
| K241856 | Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe) | Hlb Lifescience Co., Ltd. | Dec 23, 2024 | SESE |
| K242099 | Sol-M Slip Tip Syringe without Needle, Sol-M Eccentric Tip Syringe without Needle | Sol-Millennium Medical, Inc. | Oct 22, 2024 | SESE |
| K241821 | Luer Lock Syringe with Safety Needle; Luer Lock Syringe with Exchangeable Needle; Luer Lock Syringe with Blunt Fill Needle | Sol-Millennium Medical, Inc. | Sep 20, 2024 | SESE |
| K231095 | Tamper Evident Cap | International Medical Industries, Inc. | Sep 4, 2024 | SESE |
Top Applicants
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 23 clearances
- Sherwood Medical Co. — 20 clearances
- Becton, Dickinson and Company — 13 clearances
- Merit Medical Systems, Inc. — 10 clearances
- Terumo Medical Corp. — 10 clearances
