FDA product code NAS: Tympanometer
NAS is the FDA product code for tympanometer. It is a Class II device, regulated under 21 CFR 874.1090 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 2 510(k) submissions under NAS. The average 510(k) review took 88 days (median 88).
Classification
| Field | Value |
|---|---|
| Device name | Tympanometer |
| Device class | Class II |
| Regulation | 21 CFR 874.1090 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for NAS
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 88 |
Compare with all 510(k) review times · Search every NAS clearance
Top NAS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Amplivox, Ltd. | 2 | 2017-07-28 |
Most recent NAS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K171265 | Amplivox, Ltd. | Otowave 302 Portable Tympanometer | 2017-07-28 | 88 |
| K150163 | Amplivox, Ltd. | Otowave 202 Portable Tympanometer | 2015-04-23 | 87 |
Recalls for NAS devices
openFDA lists no recalls for product code NAS.
Frequently asked questions
What is FDA product code NAS?
NAS is the FDA product code for tympanometer. It is a Class II device, regulated under 21 CFR 874.1090 and reviewed by the Ear, Nose and Throat panel.
What device class is NAS?
Class II, regulation 21 CFR 874.1090. Typical premarket route: 510(k).
How long does a 510(k) take for product code NAS?
Across 2 cleared submissions the average was 88 days from receipt to decision (median 88).
Which companies have the most NAS clearances?
Amplivox, Ltd. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code NAS
- Run a recall and safety report across every NAS manufacturer
- Watch product code NAS 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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