FDA product code EWD: Protector, Hearing (Insert)
EWD is the FDA product code for protector, hearing (insert). It is a Unclassified device, reviewed by the Ear, Nose and Throat panel. FDA has cleared 14 510(k) submissions under EWD, from 11 different applicants. The average 510(k) review took 131 days (median 108).
Classification
| Field | Value |
|---|---|
| Device name | Protector, Hearing (Insert) |
| 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 EWD clearance
Top EWD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Virtual Corp. | 2 | 1996-04-03 |
| Doc'S Proplugs, Inc. | 2 | 1995-11-14 |
| Flents Products Co., Inc. | 2 | 1992-06-30 |
| Apothecary Products, Inc. | 1 | 2002-06-25 |
| Interview Medical Technology Corp. | 1 | 1997-10-27 |
6 more applicants have EWD clearances. See the full list in Caduvo.
Most recent EWD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K020296 | Apothecary Products, Inc. | ADULT SILICONE EAR PLUGS, MODELS # 68053, 68057 | 2002-06-25 | 148 |
| K972923 | Interview Medical Technology Corp. | SUPER SILIPLUGS EAR PLUGS | 1997-10-27 | 80 |
| K971517 | Bentec Medical, Inc. | SILICONE PUTTY EAR PLUGS | 1997-06-02 | 38 |
| K962292 | Emtech Laboratories | HEARSAVER | 1996-10-29 | 137 |
| K960500 | Virtual Corp. | THE VIRTUAL M-332 | 1996-04-03 | 61 |
Recalls for EWD devices
openFDA lists no recalls for product code EWD.
Frequently asked questions
What is FDA product code EWD?
EWD is the FDA product code for protector, hearing (insert). It is a Unclassified device, reviewed by the Ear, Nose and Throat panel.
What device class is EWD?
Unclassified. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EWD?
Across 14 cleared submissions the average was 131 days from receipt to decision (median 108).
Which companies have the most EWD clearances?
Virtual Corp. (2); Doc'S Proplugs, Inc. (2); Flents Products Co., Inc. (2); Apothecary Products, Inc. (1); Interview Medical Technology Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EWD
- Run a recall and safety report across every EWD manufacturer
- Watch product code EWD 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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