FMF — Syringe, Piston Class II
FDA product code FMF covers "Syringe, Piston", a Class II medical device regulated under 21 CFR 880.5860. Submissions are reviewed by the General Hospital panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K260208 | embecta medical ii | Ultra-Fine SAFETY Insulin Syringe | July 13, 2026 |
| K253110 | sol-millennium medical | Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe | June 18, 2026 |
| K260514 | cmt health pte | Profoject Safety Needle; Profoject Syringe with Safety Needle; Profoject Low | June 12, 2026 |
| K253112 | hlb lifescience co | Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); | May 21, 2026 |
| K252279 | chirana t.injecta,a.s | Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml) | April 17, 2026 |
| 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 |