Product code EWO: 510(k) clearances and predicates
Product code EWO covers OtoNova/OtoNova Pro. FDA lists 235 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
235 clearances on file under product code EWO. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 2 |
| 2025 | 0 |
| 2026 so far | 0 |
Recent clearances
Newest EWO clearances in the FDA index, with applicant and decision date:
- K234095, OtoNova/OtoNova Pro, applicant Otodynamics, decided 2024-06-21. FDA record
- K240430, Otoport Pro, applicant Otodynamics, Ltd., decided 2024-03-15. FDA record
- K231545, hearOAE, applicant Hearx SA (Pty) , Ltd., decided 2023-10-27. FDA record
- K213345, Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONE, applicant Path Medical GmbH, decided 2022-06-22. FDA record
- K191372, Lyra, applicant Interacoustics A/S, decided 2019-07-15. FDA record
- K180287, GSI Corti, applicant Grason-Stadler, Inc., decided 2018-05-11. FDA record
- K173567, Sera, applicant Interacoustics A/S, decided 2018-02-14. FDA record
- K172403, GSI Novus, applicant Grason-Stadler, Inc., decided 2017-10-20. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include Otoport Pro, hearOAE. Watch new EWO clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code EWO?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent EWO clearances include OtoNova/OtoNova Pro.
How many 510(k) clearances use product code EWO?
235 at the time this page was generated, from openFDA records.
How do I find a predicate device under EWO?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new EWO clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.