Micro Audiometrics Corp.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Micro Audiometrics Corp.” (first 1981, latest 1998), across 1 product code in 1 review panel. Median 510(k) review time under this name: 83 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EWO | Audiometer | 6 | 6 |
Review panels
Most recent Micro Audiometrics Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K982878 | EARSCAN 3 | EWO | 1998-11-03 | 81 |
| K924543 | DSP SCREENING AUDIOMETER | EWO | 1993-02-26 | 171 |
| K913589 | EARSCAN DSP-1 PURE TONE AUDIOMETER | EWO | 1991-11-05 | 85 |
| K904270 | BIOLINK AUDIOMETER SOFTWARE ACCESSORY | EWO | 1990-10-09 | 21 |
| K883505 | BIOMETER AUDIOMETER | EWO | 1989-08-21 | 369 |
| K812529 | EARSCAN | EWO | 1981-10-14 | 42 |
Recalls
openFDA lists no recalls under a recalling firm named Micro Audiometrics Corp..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Micro Media Laboratories (52 510(k)s)
- Micro Therapeutics, Inc. (51 510(k)s)
- Micro Therapeutics, Inc. d/b/a ev3 Neurovascular (32 510(k)s)
- Micro Surgical Instruments Corp. (15 510(k)s)
- Micro Motors, Inc. (14 510(k)s)
- Micro Detect, Inc. (11 510(k)s)
- Micro Direct, Inc. (9 510(k)s)
- Micro Current Technology, Inc. (8 510(k)s)
- Micro Tronics Corp. (6 510(k)s)
- Micro Specialties, Inc. (4 510(k)s)
- Micro Dental Laboratories (3 510(k)s)
- Micro Encapsulation Tech. (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Micro Audiometrics Corp.?
FDA lists 6 510(k) clearances under the applicant name “Micro Audiometrics Corp.” (first 1981, latest 1998), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Micro Audiometrics Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Micro Audiometrics Corp. is 83 days.
Which FDA product codes appear under Micro Audiometrics Corp.?
The most frequent FDA product codes under this applicant name are EWO (Audiometer, 6).
Next steps
- See all 6 Micro Audiometrics Corp. clearances with predicates and recalls
- Run predicate analysis for product code EWO, Micro Audiometrics Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.