Solcoor, Inc.: FDA clearances and approvals
Solcoor, Inc. has 7 FDA 510(k) clearances (first 1985, latest 1989), across 3 product codes in 3 review panels. Median 510(k) review time: 214 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 | 4 | 4 |
| IPF | Stimulator, Muscle, Powered | 2 | 2 |
| BZH | Meter, Peak Flow, Spirometry | 1 | 1 |
Review panels
- Neurology (4)
- Physical Medicine (2)
- Anesthesiology (1)
Most recent Solcoor, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K882386 | AGAR 3K NEUROMUSCULAR STIMULATOR | IPF | 1989-10-18 | 495 |
| K882387 | AGAR 4000 NEUROMUSCULAR STIMULATOR | IPF | 1989-10-16 | 493 |
| K862454 | AGAR 7K TENS INSTRUMENT | GZJ | 1987-03-25 | 271 |
| K861896 | UNI-TENS XL TENS | GZJ | 1986-09-09 | 116 |
| K861895 | UNI-TENS | GZJ | 1986-09-09 | 116 |
| K861894 | AGAR 9K TENS | GZJ | 1986-09-09 | 116 |
| K851265 | PEAK FLOWMETERS FOR SPIROMETRY | BZH | 1985-10-29 | 214 |
Recalls
openFDA lists no recalls under a recalling firm named Solcoor, 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 Solcoor, Inc. have?
Solcoor, Inc. has 7 FDA 510(k) clearances (first 1985, latest 1989), across 3 product codes in 3 review panels.
How long does FDA take to clear Solcoor, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Solcoor, Inc.'s cleared 510(k)s is 214 days.
What devices does Solcoor, Inc. make?
Its most frequent FDA product codes are GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief, 4); IPF (Stimulator, Muscle, Powered, 2); BZH (Meter, Peak Flow, Spirometry, 1).
Has Solcoor, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Solcoor, Inc. Related entities may recall under other names.
Next steps
- See all 7 Solcoor, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GZJ, Solcoor, 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.