FDA product code FHT: Set, Gavage, Infant, Sterile
FHT is the FDA product code for set, gavage, infant, sterile. It is a Class II device, regulated under 21 CFR 876.5980 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 1 510(k) submission under FHT. The average 510(k) review took 27 days (median 27).
Classification
| Field | Value |
|---|---|
| Device name | Set, Gavage, Infant, Sterile |
| Device class | Class II |
| Regulation | 21 CFR 876.5980 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every FHT clearance
Top FHT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ethox Corp. | 1 | 1980-06-09 |
Most recent FHT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K801144 | Ethox Corp. | ETHOX/BARRON FOOD PUMP GAVAGE BAG SETS | 1980-06-09 | 27 |
Recalls for FHT devices
openFDA lists no recalls for product code FHT.
Frequently asked questions
What is FDA product code FHT?
FHT is the FDA product code for set, gavage, infant, sterile. It is a Class II device, regulated under 21 CFR 876.5980 and reviewed by the Gastroenterology and Urology panel.
What device class is FHT?
Class II, regulation 21 CFR 876.5980. Typical premarket route: 510(k).
How long does a 510(k) take for product code FHT?
Across 1 cleared submissions the average was 27 days from receipt to decision (median 27).
Which companies have the most FHT clearances?
Ethox Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FHT
- Run a recall and safety report across every FHT manufacturer
- Watch product code FHT 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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