FMF — Syringe, Piston Class II
FDA Device Classification
Classification Details
- Product Code
- FMF
- Device Class
- Class II
- Regulation Number
- 880.5860
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K253068 | cmt health pte | Profoject Insulin Syringes; Profoject Safelock Disposable Insulin Syringe | February 23, 2026 |
| K253769 | instylla | Instylla Delivery Kit | December 22, 2025 |
| K252518 | duopross meditech corporate | DuoprossTM Smart Cap (Type I) | December 17, 2025 |
| K251089 | exelint international | EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Sy | December 12, 2025 |
| K250192 | promisemed hangzhou meditech co | Verisafe Safety Retractable Insulin Syringes | December 10, 2025 |
| K250853 | merit medical systems | Merit Syringe | November 4, 2025 |
| K250510 | shina med corporation | Sure-Fine Insulin Syringes | October 15, 2025 |
| K243660 | cardinalhealth | Monoject 1mL Tuberculin Syringe Luer-Lock Tip (1180100777); Monoject 3mL Syri | August 22, 2025 |
| K251350 | becton, dickinson and | BD Plastipak Syringe | July 29, 2025 |
| K252033 | cmt health pte | Profoject Disposable Syringe, Profoject Disposable Syringe with Needle | July 25, 2025 |
| K250733 | bimed teknik aletler sanayi and ticaret a.s | 3DOSE 1ml Syringe | July 3, 2025 |
| K251648 | prosidyan | GPS Advanced; GPS Advanced Cannula | June 24, 2025 |
| K250262 | go-pen aps | GO-PEN® | April 24, 2025 |
| K243580 | surgentec | GraftGun Universal Graft Delivery System (GDS) | February 5, 2025 |
| K242434 | chirana t. injecta | Insulin Syringes | December 24, 2024 |
| K241856 | hlb lifescience co | Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); | December 23, 2024 |
| K242099 | sol-millennium medical | Sol-M Slip Tip Syringe without Needle, Sol-M Eccentric Tip Syringe without Nee | October 22, 2024 |
| K241821 | sol-millennium medical | Luer Lock Syringe with Safety Needle; Luer Lock Syringe with Exchangeable Needle | September 20, 2024 |
| K231095 | international medical industries | Tamper Evident Cap | September 4, 2024 |
| K240961 | wuxi nest biotechnology co | Disposable Pen Injector Assembly | August 15, 2024 |