FDA product code ESE: Larynx, Artificial (Battery-Powered)
ESE is the FDA product code for larynx, artificial (battery-powered). It is a Class I device, regulated under 21 CFR 874.3375 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 13 510(k) submissions under ESE, from 12 different applicants. The average 510(k) review took 127 days (median 85).
Classification
| Field | Value |
|---|---|
| Device name | Larynx, Artificial (Battery-Powered) |
| Device class | Class I |
| Regulation | 21 CFR 874.3375 |
| 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 ESE clearance
Top ESE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bloomfield Research and Development, Inc. | 2 | 1986-05-02 |
| Mountain Precision Mfg. Ltd. Co. | 1 | 1994-03-16 |
| Denrick Corp. | 1 | 1993-08-25 |
| Bruce Medical Supply | 1 | 1993-04-07 |
| Ultravoice, Ltd. | 1 | 1993-02-12 |
7 more applicants have ESE clearances. See the full list in Caduvo.
Most recent ESE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K934483 | Mountain Precision Mfg. Ltd. Co. | NU-VOIS BATTERY POWERED ARTIFICIAL LARYNX | 1994-03-16 | 183 |
| K931371 | Denrick Corp. | DENRICK SPEECH AID (DR-1) | 1993-08-25 | 161 |
| K923648 | Bruce Medical Supply | LECTRO-LARYNX | 1993-04-07 | 260 |
| K914816 | Ultravoice, Ltd. | AMERICAN ARTIFICIAL LARYNX | 1993-02-12 | 476 |
| K901503 | Stanton Magnetics, Inc. | ADDVOX BONE CONDUCTOR AMPLIFIER SPEAKER SYSTEM | 1990-06-28 | 90 |
Recalls for ESE devices
openFDA lists no recalls for product code ESE.
Frequently asked questions
What is FDA product code ESE?
ESE is the FDA product code for larynx, artificial (battery-powered). It is a Class I device, regulated under 21 CFR 874.3375 and reviewed by the Ear, Nose and Throat panel.
What device class is ESE?
Class I, regulation 21 CFR 874.3375. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code ESE?
Across 13 cleared submissions the average was 127 days from receipt to decision (median 85).
Which companies have the most ESE clearances?
Bloomfield Research and Development, Inc. (2); Mountain Precision Mfg. Ltd. Co. (1); Denrick Corp. (1); Bruce Medical Supply (1); Ultravoice, Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code ESE
- Run a recall and safety report across every ESE manufacturer
- Watch product code ESE 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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