FDA product code ETY: Tester, Auditory Impedance
ETY is the FDA product code for tester, auditory impedance. It is a Class II device, regulated under 21 CFR 874.1090 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 70 510(k) submissions under ETY, from 37 different applicants. The average 510(k) review took 93 days (median 90). FDA has posted 1 recall for ETY devices.
Classification
| Field | Value |
|---|---|
| Device name | Tester, Auditory Impedance |
| Device class | Class II |
| Regulation | 21 CFR 874.1090 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for ETY
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 118 |
| 2019 | 1 | 107 |
Compare with all 510(k) review times · Search every ETY clearance
Top ETY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| American Electromedics Corp. | 12 | 1998-11-18 |
| Maico Hearing Instruments, Inc. | 5 | 1995-07-24 |
| Teledyne Avionics Div. of Teledyne | 5 | 1986-04-23 |
| Idem (Int'L Dist. of Electronics For Medicine) | 3 | 1999-05-17 |
| Madsen Electronics (Canada) , Ltd. | 3 | 1991-06-19 |
32 more applicants have ETY clearances. See the full list in Caduvo.
Most recent ETY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K183201 | Db Diagnostic Systems, Inc. | Hearing Healthcare Pro | 2019-03-06 | 107 |
| K171038 | Db Diagnostic Systems, Inc. | Hearing Healthcare Pro | 2017-08-02 | 118 |
| K162210 | Maico Diagnostics GmbH | touchTymp | 2016-11-16 | 103 |
| K161707 | Gn Otometrics | Madsen Zodiac | 2016-09-01 | 72 |
| K151616 | Interacoustics A/S | AT235 | 2015-07-15 | 30 |
Recalls for ETY devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2005-06-27.
Frequently asked questions
What is FDA product code ETY?
ETY is the FDA product code for tester, auditory impedance. It is a Class II device, regulated under 21 CFR 874.1090 and reviewed by the Ear, Nose and Throat panel.
What device class is ETY?
Class II, regulation 21 CFR 874.1090. Typical premarket route: 510(k).
How long does a 510(k) take for product code ETY?
Across 70 cleared submissions the average was 93 days from receipt to decision (median 90).
Which companies have the most ETY clearances?
American Electromedics Corp. (12); Maico Hearing Instruments, Inc. (5); Teledyne Avionics Div. of Teledyne (5); Idem (Int'L Dist. of Electronics For Medicine) (3); Madsen Electronics (Canada) , Ltd. (3).
Have ETY devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2005-06-27.
Next steps
- Run an FDA pathway report with predicate devices for product code ETY
- Run a recall and safety report across every ETY manufacturer
- Watch product code ETY 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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