Frye Electronics, Inc.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Frye Electronics, Inc.” (first 1980, latest 2013), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 66 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 | 1 | 123 |
| 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 |
|---|---|---|---|
| ETW | Calibrator, Hearing Aid / Earphone And Analysis Systems | 9 | 9 |
| EWO | Audiometer | 2 | 2 |
| GWJ | Stimulator, Auditory, Evoked Response | 1 | 1 |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 1 | 1 |
Review panels
- Ear, Nose and Throat (11)
- Neurology (2)
Most recent Frye Electronics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K123701 | HEARLAB ACA | GWJ | 2013-04-05 | 123 |
| K093006 | FONIX ,MODEL 8000 | ETW | 2009-12-30 | 93 |
| K022510 | FONIX, MODEL 7000 | ETW | 2002-08-27 | 28 |
| K980377 | FONIX FP35 HEARING AID ANALYZER | ETW | 1998-03-18 | 44 |
| K935400 | FONIX 3500 HEARING AID ANALYZER | ETW | 1994-01-14 | 66 |
| K913221 | TYPE FA10 AUDIOMETER | EWO | 1991-10-11 | 84 |
| K895383 | TYPE FP40 DIGITAL HEARING AID ANALYZER | ETW | 1990-01-22 | 145 |
| K872242 | TYPE 6400 REAL EAR HEARING AID ANALYZER | ETW | 1987-07-10 | 29 |
| K861571 | TYPE 6500 HEARING AID ANALYZER | ETW | 1986-05-30 | 32 |
| K850918 | TYPE FP30 DIGITAL HEARING AID ANALYZER | ETW | 1985-05-29 | 85 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Frye Electronics, Inc..
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.
- Frye Health Systems (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Frye Electronics, Inc.?
FDA lists 13 510(k) clearances under the applicant name “Frye Electronics, Inc.” (first 1980, latest 2013), across 4 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Frye Electronics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Frye Electronics, Inc. is 66 days.
Which FDA product codes appear under Frye Electronics, Inc.?
The most frequent FDA product codes under this applicant name are ETW (Calibrator, Hearing Aid / Earphone And Analysis Systems, 9); EWO (Audiometer, 2); GWJ (Stimulator, Auditory, Evoked Response, 1).
Next steps
- See all 13 Frye Electronics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code ETW, Frye Electronics, Inc.'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.