FDA product code FMA: Depressor, Tongue, Non-Surgical
FMA is the FDA product code for depressor, tongue, non-surgical. It is a Class I device, regulated under 21 CFR 880.6230 and reviewed by the General Hospital panel. FDA has cleared 5 510(k) submissions under FMA, from 5 different applicants. The average 510(k) review took 63 days (median 32).
Classification
| Field | Value |
|---|---|
| Device name | Depressor, Tongue, Non-Surgical |
| Device class | Class I |
| Regulation | 21 CFR 880.6230 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every FMA clearance
Top FMA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Aga Plastic Ind. Com. Ltda. | 1 | 1999-12-09 |
| The Torrent Corp. | 1 | 1984-11-30 |
| Pharmaquest Corp. | 1 | 1983-04-08 |
| Abco Dealers, Inc. | 1 | 1982-05-21 |
| Pharmaseal Div., Baxter Healthcare Corp. | 1 | 1977-01-28 |
Most recent FMA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K992995 | Aga Plastic Ind. Com. Ltda. | AROMATIC AND FLAVORED TONGUE DEPRESSOR | 1999-12-09 | 93 |
| K842461 | The Torrent Corp. | TONGUE DEPRESSOR | 1984-11-30 | 161 |
| K830705 | Pharmaquest Corp. | MINI LANCET-BLOOD LANCET | 1983-04-08 | 32 |
| K821177 | Abco Dealers, Inc. | BITE STICK | 1982-05-21 | 24 |
| K770120 | Pharmaseal Div., Baxter Healthcare Corp. | MOUTH WASH TRAY | 1977-01-28 | 7 |
Recalls for FMA devices
openFDA lists no recalls for product code FMA.
Frequently asked questions
What is FDA product code FMA?
FMA is the FDA product code for depressor, tongue, non-surgical. It is a Class I device, regulated under 21 CFR 880.6230 and reviewed by the General Hospital panel.
What device class is FMA?
Class I, regulation 21 CFR 880.6230. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FMA?
Across 5 cleared submissions the average was 63 days from receipt to decision (median 32).
Which companies have the most FMA clearances?
Aga Plastic Ind. Com. Ltda. (1); The Torrent Corp. (1); Pharmaquest Corp. (1); Abco Dealers, Inc. (1); Pharmaseal Div., Baxter Healthcare Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FMA
- Run a recall and safety report across every FMA manufacturer
- Watch product code FMA 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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