Product code FMI: 510(k) clearances and predicates
Product code FMI covers MOWANA Auto Duo. FDA lists 694 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
694 clearances on file under product code FMI. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 23 |
| 2023 | 18 |
| 2024 | 3 |
| 2025 | 11 |
| 2026 so far | 12 |
Recent clearances
Newest FMI clearances in the FDA index, with applicant and decision date:
- K261266, MOWANA Auto Duo, applicant PENTAMASTER MEDIQ SDN BHD, decided 2026-09-17. FDA record
- K261719, Promisemed X-Safety Pen Needle, applicant Promisemed Hangzhou Meditech Co., Ltd., decided 2026-08-25. FDA record
- K262427, Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII), applicant Hh Global Technology, Inc., decided 2026-08-10. FDA record
- K260933, Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T), applicant Hangzhou Qiantang Longyue Biotechnology Co., Ltd., decided 2026-08-07. FDA record
- K261829, Profoject Dual-Safety Pen Needles, applicant CMT Health PTE., Ltd., decided 2026-07-29. FDA record
- K260739, Profoject Pen Needles (Model A; Model B), applicant CMT Health PTE., Ltd., decided 2026-07-15. FDA record
- K260855, Profoject Safety Pen Needles, applicant CMT Health PTE., Ltd., decided 2026-06-10. FDA record
- K254273, Verisafe Safety Sterile Needles (SSN), applicant Promisemed Hangzhou Meditech Co., Ltd., decided 2026-04-16. 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 Promisemed X-Safety Pen Needle, Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII). Watch new FMI 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 FMI?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent FMI clearances include MOWANA Auto Duo.
How many 510(k) clearances use product code FMI?
694 at the time this page was generated, from openFDA records.
How do I find a predicate device under FMI?
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 FMI clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.