Biostim, Inc.: FDA clearances and approvals
Biostim, Inc. has 5 FDA 510(k) clearances (first 1980, latest 1985), across 4 product codes in 2 review panels. Median 510(k) review time: 14 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 | 2 | 2 |
| GXY | Electrode, Cutaneous | 1 | 1 |
| IPF | Stimulator, Muscle, Powered | 1 | 1 |
Plus 1 more product codes.
Review panels
- Neurology (3)
- Physical Medicine (1)
Most recent Biostim, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K844023 | AQUAFORM ELECTRODES WITH AQUAPORE | GXY | 1985-02-01 | 109 |
| K840725 | CLINICAL CARE STIMULATOR | — | 1984-04-18 | 57 |
| K840724 | MUSCLE STIMULATOR X-10 | IPF | 1984-03-05 | 13 |
| K820678 | SYSTEM 10 | GZJ | 1982-03-23 | 12 |
| K802227 | ANASTIM II TRANSCUTANEOUS ELECTRICAL | GZJ | 1980-09-26 | 14 |
Recalls
openFDA lists no recalls under a recalling firm named Biostim, 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 Biostim, Inc. have?
Biostim, Inc. has 5 FDA 510(k) clearances (first 1980, latest 1985), across 4 product codes in 2 review panels.
How long does FDA take to clear Biostim, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Biostim, Inc.'s cleared 510(k)s is 14 days.
What devices does Biostim, Inc. make?
Its most frequent FDA product codes are GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief, 2); GXY (Electrode, Cutaneous, 1); IPF (Stimulator, Muscle, Powered, 1).
Has Biostim, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Biostim, Inc. Related entities may recall under other names.
Next steps
- See all 5 Biostim, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GZJ, Biostim, 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.