FDA product code FMF: Syringe, Piston
FMF is the FDA product code for syringe, piston. It is a Class II device, regulated under 21 CFR 880.5860 and reviewed by the General Hospital panel. FDA has cleared 752 510(k) submissions under FMF, 82 in the last five years, from 455 different applicants. The average 510(k) review took 125 days (median 87); 181 days on average over the last three years. FDA has posted 305 recalls for FMF devices, 145 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Syringe, Piston |
| Device class | Class II |
| Regulation | 21 CFR 880.5860 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for FMF
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 13 | 154 |
| 2018 | 8 | 131 |
| 2019 | 11 | 172 |
| 2020 | 15 | 138 |
| 2021 | 20 | 176 |
| 2022 | 24 | 253 |
| 2023 | 22 | 266 |
| 2024 | 14 | 186 |
| 2025 | 13 | 144 |
| 2026 | 9 | 213 |
Compare with all 510(k) review times · Search every FMF clearance
Top FMF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 23 | 1998-07-15 |
| Sherwood Medical Co. | 20 | 1995-03-01 |
| Becton, Dickinson and Company | 13 | 2025-07-29 |
| Merit Medical Systems, Inc. | 10 | 2025-11-04 |
| Terumo Medical Corp. | 10 | 2007-07-11 |
450 more applicants have FMF clearances. See the full list in Caduvo.
Most recent FMF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K262581 | SurGenTec, LLC | GraftGun Universal Graft Delivery System (GDS®) | 2026-08-26 | 30 |
| K252184 | Sol-Millennium Medical, Inc. | SOL-M Luer Lock Syringe with Exchangeable Needle Tray | 2026-08-25 | 410 |
| K253747 | Jiangsu Enjosim Medical Technology Co., Ltd. | Disposable Pen Injector (KXYC-03C02, KXYC-03A03) | 2026-08-14 | 262 |
| K260208 | embecta Medical II, LLC | Ultra-Fine SAFETY Insulin Syringe | 2026-07-13 | 171 |
| K253110 | Sol-Millennium Medical, Inc. | Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe | 2026-06-18 | 267 |
Recalls for FMF devices
305 product recalls in 96 recall events; 145 initiated in the last five years and 144 still open. Most recent: 2026-04-28.
| Year | Recalls |
|---|---|
| 2017 | 42 |
| 2018 | 7 |
| 2019 | 2 |
| 2020 | 16 |
| 2021 | 1 |
| 2022 | 3 |
| 2023 | 30 |
| 2024 | 100 |
| 2025 | 7 |
| 2026 | 4 |
Frequently asked questions
What is FDA product code FMF?
FMF is the FDA product code for syringe, piston. It is a Class II device, regulated under 21 CFR 880.5860 and reviewed by the General Hospital panel.
What device class is FMF?
Class II, regulation 21 CFR 880.5860. Typical premarket route: 510(k).
How long does a 510(k) take for product code FMF?
Across 752 cleared submissions the average was 125 days from receipt to decision (median 87).
Which companies have the most FMF clearances?
Bd Becton Dickinson Vacutainer Systems Preanalytic (23); Sherwood Medical Co. (20); Becton, Dickinson and Company (13); Merit Medical Systems, Inc. (10); Terumo Medical Corp. (10).
Have FMF devices been recalled?
Yes: 305 product recalls across 96 recall events; the most recent began 2026-04-28.
Next steps
- Run an FDA pathway report with predicate devices for product code FMF
- Run a recall and safety report across every FMF manufacturer
- Watch product code FMF for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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