Grason-Stadler, Inc.: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “Grason-Stadler, Inc.” (first 1979, latest 2018), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 76 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 | 1 | 72 |
| 2018 | 1 | 99 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Grason-Stadler, Inc. took a median 86 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 116 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EWO | Audiometer | 12 | 12 |
| ETY | Tester, Auditory Impedance | 2 | 2 |
| ETW | Calibrator, Hearing Aid / Earphone And Analysis Systems | 1 | 1 |
| GWJ | Stimulator, Auditory, Evoked Response | 1 | 1 |
Review panels
- Ear, Nose and Throat (15)
- Neurology (1)
Most recent Grason-Stadler, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K180287 | GSI Corti | EWO | 2018-05-11 | 99 |
| K172403 | GSI Novus | EWO | 2017-10-20 | 72 |
| K000097 | GSI 2000 MIDDLE EAR ANALYZER | ETY | 2000-04-12 | 90 |
| K974237 | GSI 70 AUDIOPATH SCREENER | EWO | 1998-02-10 | 90 |
| K970324 | GSI SA60 DPOAE SYSTEM | ETW | 1997-06-06 | 130 |
| K953684 | GSI 61 CLINICAL AUDIOMETER | EWO | 1995-10-27 | 85 |
| K951759 | GSI 65 COMPUTERIZED AUDIOMETER | EWO | 1995-07-06 | 80 |
| K902540 | GSI 17 SCREENING AUDIOMETER | EWO | 1990-07-13 | 37 |
| K890124 | ILO88 OTODYNAMIC ANALYZER SCREENING AUDIOMETER | EWO | 1989-07-14 | 184 |
| K870030 | THE SCREENER GSI 55 ABR SCREENER | GWJ | 1987-03-13 | 67 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Grason-Stadler, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Grason-Stadler, Inc.?
FDA lists 16 510(k) clearances under the applicant name “Grason-Stadler, Inc.” (first 1979, latest 2018), 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 Grason-Stadler, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Grason-Stadler, Inc. is 76 days.
Which FDA product codes appear under Grason-Stadler, Inc.?
The most frequent FDA product codes under this applicant name are EWO (Audiometer, 12); ETY (Tester, Auditory Impedance, 2); ETW (Calibrator, Hearing Aid / Earphone And Analysis Systems, 1).
Next steps
- See all 16 Grason-Stadler, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EWO, Grason-Stadler, 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.