FDA product code ERA: Otoscope
ERA is the FDA product code for otoscope. It is a Class I device, regulated under 21 CFR 874.4770 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 56 510(k) submissions under ERA, from 31 different applicants. The average 510(k) review took 102 days (median 82). FDA has posted 1 recall for ERA devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Otoscope |
| Device class | Class I |
| Regulation | 21 CFR 874.4770 |
| 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 ERA clearance
Top ERA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Welch Allyn, Inc. | 9 | 1995-11-14 |
| Rudolf Riester GmbH & Co. KG | 9 | 1995-05-12 |
| Jedmed Instrument Co. | 4 | 1994-09-23 |
| Pedia Pals, Inc. | 3 | 1995-04-17 |
| Introspect, Inc. | 2 | 1995-04-13 |
26 more applicants have ERA clearances. See the full list in Caduvo.
Most recent ERA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K123821 | Blue Focus | AIO HD OTOSCOPE | 2013-05-17 | 156 |
| K121326 | Lantos Technologies | LANTOS 3D EAR SCANNER | 2013-01-25 | 268 |
| K110326 | Osram Sylvania, Inc. | OSRAM ITOS | 2011-10-27 | 266 |
| K945264 | Optus, Inc. | OPTUS OTOSCOPES | 1996-02-02 | 462 |
| K955043 | Welch Allyn, Inc. | WELCH ALLYN BI-OTOSCOPE | 1995-11-14 | 11 |
Recalls for ERA devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-05-09.
| Year | Recalls |
|---|---|
| 2025 | 1 |
Frequently asked questions
What is FDA product code ERA?
ERA is the FDA product code for otoscope. It is a Class I device, regulated under 21 CFR 874.4770 and reviewed by the Ear, Nose and Throat panel.
What device class is ERA?
Class I, regulation 21 CFR 874.4770. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code ERA?
Across 56 cleared submissions the average was 102 days from receipt to decision (median 82).
Which companies have the most ERA clearances?
Welch Allyn, Inc. (9); Rudolf Riester GmbH & Co. KG (9); Jedmed Instrument Co. (4); Pedia Pals, Inc. (3); Introspect, Inc. (2).
Have ERA devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2025-05-09.
Next steps
- Run an FDA pathway report with predicate devices for product code ERA
- Run a recall and safety report across every ERA manufacturer
- Watch product code ERA 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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