FDA product code ETS: Generator, Electronic Noise (For Audiometric Testing)
ETS is the FDA product code for generator, electronic noise (for audiometric testing). It is a Class II device, regulated under 21 CFR 874.1120 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 5 510(k) submissions under ETS, from 3 different applicants. The average 510(k) review took 23 days (median 23).
Classification
| Field | Value |
|---|---|
| Device name | Generator, Electronic Noise (For Audiometric Testing) |
| Device class | Class II |
| Regulation | 21 CFR 874.1120 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every ETS clearance
Top ETS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Western Advanced Technology, Inc. | 3 | 1982-01-19 |
| Vicon Instrument Co. | 1 | 1979-02-16 |
| Teca, Inc. | 1 | 1977-07-14 |
Most recent ETS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K813557 | Western Advanced Technology, Inc. | AUDITORY STIMULATOR | 1982-01-19 | 28 |
| K811772 | Western Advanced Technology, Inc. | AUDITORY LOCALIZER | 1981-07-15 | 23 |
| K811790 | Western Advanced Technology, Inc. | OCTOTOXIC SCREENER | 1981-07-15 | 21 |
| K790064 | Vicon Instrument Co. | TINNITUS DEVICES | 1979-02-16 | 32 |
| K771188 | Teca, Inc. | REVERSING CLICK GENERATOR RCG6 | 1977-07-14 | 13 |
Recalls for ETS devices
openFDA lists no recalls for product code ETS.
Frequently asked questions
What is FDA product code ETS?
ETS is the FDA product code for generator, electronic noise (for audiometric testing). It is a Class II device, regulated under 21 CFR 874.1120 and reviewed by the Ear, Nose and Throat panel.
What device class is ETS?
Class II, regulation 21 CFR 874.1120. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code ETS?
Across 5 cleared submissions the average was 23 days from receipt to decision (median 23).
Which companies have the most ETS clearances?
Western Advanced Technology, Inc. (3); Vicon Instrument Co. (1); Teca, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code ETS
- Run a recall and safety report across every ETS manufacturer
- Watch product code ETS 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.
All Ear, Nose and Throat product codes · FDA product code lookup · 510(k) database search · 510(k) review times