Staodyne, Inc.: FDA clearances and approvals
Staodyne, Inc. has 9 FDA 510(k) clearances (first 1992, latest 1995), across 3 product codes in 2 review panels. Median 510(k) review time: 122 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 |
|---|---|---|---|
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 5 | 5 |
| IPF | Stimulator, Muscle, Powered | 3 | 3 |
| GXY | Electrode, Cutaneous | 1 | 1 |
Review panels
- Neurology (6)
- Physical Medicine (3)
Most recent Staodyne, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K952680 | VARAPULSE-2 | IPF | 1995-12-04 | 175 |
| K941923 | STERILE TREATMENT ELECTRODE | GZJ | 1995-06-02 | 408 |
| K931925 | TPK CUTANEOUS ELECTRODE | GXY | 1993-08-16 | 122 |
| K926510 | STAODYN EMS+2 | IPF | 1993-08-11 | 224 |
| K931424 | MAXIMA I | GZJ | 1993-06-04 | 74 |
| K930865 | STAODYN MAXIMA III | GZJ | 1993-05-13 | 84 |
| K925898 | MODEL 19 STIMULATOR, NERVE, TRANSCUTANEOUS | GZJ | 1993-01-28 | 69 |
| K921110 | TENS | GZJ | 1992-08-14 | 158 |
| K921668 | STAODYN TUWAVE | IPF | 1992-08-03 | 117 |
Recalls
openFDA lists no recalls under a recalling firm named Staodyne, 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 Staodyne, Inc. have?
Staodyne, Inc. has 9 FDA 510(k) clearances (first 1992, latest 1995), across 3 product codes in 2 review panels.
How long does FDA take to clear Staodyne, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Staodyne, Inc.'s cleared 510(k)s is 122 days.
What devices does Staodyne, Inc. make?
Its most frequent FDA product codes are GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief, 5); IPF (Stimulator, Muscle, Powered, 3); GXY (Electrode, Cutaneous, 1).
Has Staodyne, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Staodyne, Inc. Related entities may recall under other names.
Next steps
- See all 9 Staodyne, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GZJ, Staodyne, 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.