FDA product code EWA: Set, Audiometer Calibration
EWA is the FDA product code for set, audiometer calibration. It is a Class I device, regulated under 21 CFR 874.1080 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 2 510(k) submissions under EWA, from 2 different applicants. The average 510(k) review took 115 days (median 115).
Classification
| Field | Value |
|---|---|
| Device name | Set, Audiometer Calibration |
| Device class | Class I |
| Regulation | 21 CFR 874.1080 |
| 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 EWA clearance
Top EWA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Smith & Nephew Richards, Inc. | 1 | 1994-04-25 |
| Tracor Instruments, Inc. | 1 | 1978-03-30 |
Most recent EWA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K934432 | Smith & Nephew Richards, Inc. | OTOVIEW ENDOSCOPY SYSTEM | 1994-04-25 | 224 |
| K780474 | Tracor Instruments, Inc. | AUDIOMETER CALIBRATOR MODEL RA 310 | 1978-03-30 | 6 |
Recalls for EWA devices
openFDA lists no recalls for product code EWA.
Frequently asked questions
What is FDA product code EWA?
EWA is the FDA product code for set, audiometer calibration. It is a Class I device, regulated under 21 CFR 874.1080 and reviewed by the Ear, Nose and Throat panel.
What device class is EWA?
Class I, regulation 21 CFR 874.1080. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EWA?
Across 2 cleared submissions the average was 115 days from receipt to decision (median 115).
Which companies have the most EWA clearances?
Smith & Nephew Richards, Inc. (1); Tracor Instruments, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EWA
- Run a recall and safety report across every EWA manufacturer
- Watch product code EWA 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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