FDA product code FNC: Tent, Pediatric Aerosol
FNC is the FDA product code for tent, pediatric aerosol. It is a Class II device, regulated under 21 CFR 868.5710 and reviewed by the Anesthesiology panel. FDA has cleared 1 510(k) submission under FNC. The average 510(k) review took 67 days (median 67).
Classification
| Field | Value |
|---|---|
| Device name | Tent, Pediatric Aerosol |
| Device class | Class II |
| Regulation | 21 CFR 868.5710 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every FNC clearance
Top FNC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cal-Trends Products | 1 | 1989-02-03 |
Most recent FNC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K884922 | Cal-Trends Products | THE BREATHE EASE NURSERY VAPOR TENT | 1989-02-03 | 67 |
Recalls for FNC devices
openFDA lists no recalls for product code FNC.
Frequently asked questions
What is FDA product code FNC?
FNC is the FDA product code for tent, pediatric aerosol. It is a Class II device, regulated under 21 CFR 868.5710 and reviewed by the Anesthesiology panel.
What device class is FNC?
Class II, regulation 21 CFR 868.5710. Typical premarket route: 510(k).
How long does a 510(k) take for product code FNC?
Across 1 cleared submissions the average was 67 days from receipt to decision (median 67).
Which companies have the most FNC clearances?
Cal-Trends Products (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FNC
- Run a recall and safety report across every FNC manufacturer
- Watch product code FNC 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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