FDA product code EWE: Protector, Hearing (Circumaural)
EWE is the FDA product code for protector, hearing (circumaural). It is a Unclassified device, reviewed by the Ear, Nose and Throat panel. FDA has cleared 1 510(k) submission under EWE. The average 510(k) review took 468 days (median 468).
Classification
| Field | Value |
|---|---|
| Device name | Protector, Hearing (Circumaural) |
| Device class | Unclassified |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Unknown |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every EWE clearance
Top EWE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Natus Medical, Inc. | 1 | 1995-02-09 |
Most recent EWE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K935160 | Natus Medical, Inc. | MINIMUFFS | 1995-02-09 | 468 |
Recalls for EWE devices
openFDA lists no recalls for product code EWE.
Frequently asked questions
What is FDA product code EWE?
EWE is the FDA product code for protector, hearing (circumaural). It is a Unclassified device, reviewed by the Ear, Nose and Throat panel.
What device class is EWE?
Unclassified. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EWE?
Across 1 cleared submissions the average was 468 days from receipt to decision (median 468).
Which companies have the most EWE clearances?
Natus Medical, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EWE
- Run a recall and safety report across every EWE manufacturer
- Watch product code EWE 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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