Western Advanced Technology, Inc.: FDA clearances and approvals
Western Advanced Technology, Inc. has 6 FDA 510(k) clearances (first 1980, latest 1983), across 4 product codes in 3 review panels. Median 510(k) review time: 23 days.
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 |
|---|---|---|---|
| ETS | Generator, Electronic Noise (For Audiometric Testing) | 3 | 3 |
| EIB | Syringe, Irrigating (Dental) | 1 | 1 |
| ESD | Hearing Aid, Air-Conduction, Prescription | 1 | 1 |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 1 | 1 |
Review panels
- Ear, Nose and Throat (4)
- Dental (1)
- Neurology (1)
Most recent Western Advanced Technology, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K822411 | SYSTEM 80 FACEPLATE-IN-THE-EAR #F1 | EIB | 1983-07-12 | 336 |
| K813557 | AUDITORY STIMULATOR | ETS | 1982-01-19 | 28 |
| K812138 | TENS DEVICE | GZJ | 1981-08-20 | 23 |
| K811790 | OCTOTOXIC SCREENER | ETS | 1981-07-15 | 21 |
| K811772 | AUDITORY LOCALIZER | ETS | 1981-07-15 | 23 |
| K802324 | E1 SERIES HEARING AID | ESD | 1980-10-10 | 17 |
Recalls
openFDA lists no recalls under a recalling firm named Western Advanced Technology, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Western Advanced Technology, Inc. have?
Western Advanced Technology, Inc. has 6 FDA 510(k) clearances (first 1980, latest 1983), across 4 product codes in 3 review panels.
How long does FDA take to clear Western Advanced Technology, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Western Advanced Technology, Inc.'s cleared 510(k)s is 23 days.
What devices does Western Advanced Technology, Inc. make?
Its most frequent FDA product codes are ETS (Generator, Electronic Noise (For Audiometric Testing), 3); EIB (Syringe, Irrigating (Dental), 1); ESD (Hearing Aid, Air-Conduction, Prescription, 1).
Has Western Advanced Technology, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Western Advanced Technology, Inc. Related entities may recall under other names.
Next steps
- See all 6 Western Advanced Technology, Inc. clearances with predicates and recalls
- Run predicate analysis for product code ETS, Western Advanced Technology, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.