Product code FMF: 510(k) clearances and predicates
Product code FMF covers GraftGun Universal Graft Delivery System (GDS®). FDA lists 752 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
752 clearances on file under product code FMF. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 24 |
| 2023 | 22 |
| 2024 | 14 |
| 2025 | 13 |
| 2026 so far | 9 |
Recent clearances
Newest FMF clearances in the FDA index, with applicant and decision date:
- K262581, GraftGun Universal Graft Delivery System (GDS®), applicant SurGenTec, LLC, decided 2026-08-26. FDA record
- K252184, SOL-M Luer Lock Syringe with Exchangeable Needle Tray, applicant Sol-Millennium Medical, Inc., decided 2026-08-25. FDA record
- K253747, Disposable Pen Injector (KXYC-03C02, KXYC-03A03), applicant Jiangsu Enjosim Medical Technology Co., Ltd., decided 2026-08-14. FDA record
- K260208, Ultra-Fine SAFETY Insulin Syringe, applicant embecta Medical II, LLC, decided 2026-07-13. FDA record
- K253110, Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe, applicant Sol-Millennium Medical, Inc., decided 2026-06-18. FDA record
- K260514, Profoject Safety Needle; Profoject Syringe with Safety Needle; Profoject Low Dead Space Syringe with Safety Needle, applicant CMT Health PTE., Ltd., decided 2026-06-12. FDA record
- K253112, Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe), applicant Hlb Lifescience Co., Ltd., decided 2026-05-21. FDA record
- K252279, Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml), applicant Chirana T.Injecta,A.S., decided 2026-04-17. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include SOL-M Luer Lock Syringe with Exchangeable Needle Tray, Disposable Pen Injector (KXYC-03C02, KXYC-03A03). Watch new FMF clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code FMF?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent FMF clearances include GraftGun Universal Graft Delivery System (GDS®).
How many 510(k) clearances use product code FMF?
752 at the time this page was generated, from openFDA records.
How do I find a predicate device under FMF?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new FMF clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.