Biotrine Corp.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Biotrine Corp.” (first 1981, latest 1992), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 57 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 | 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 |
|---|---|---|---|
| BZG | Spirometer, Diagnostic | 2 | 2 |
| BZH | Meter, Peak Flow, Spirometry | 2 | 2 |
| BTI | Compressor, Air, Portable | 1 | 1 |
| JAX | Pneumotachometer | 1 | 1 |
Review panels
- Anesthesiology (6)
Most recent Biotrine Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K915060 | ASTECH HOME PEAK FLOW METER | BZH | 1992-09-11 | 308 |
| K883704 | MULTIICHALLENGE NEBULIZER SYSTEM | BTI | 1988-11-28 | 90 |
| K863134 | MULTISPIRO SA/100 | BZG | 1986-12-15 | 122 |
| K844226 | B-1000 | BZG | 1984-11-20 | 19 |
| K813414 | PEAK FLOW MONITOR | BZH | 1981-12-31 | 24 |
| K812825 | FLO-COR I | JAX | 1981-10-26 | 18 |
Recalls
openFDA lists no recalls under a recalling firm named Biotrine Corp..
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 Biotrine Corp.?
FDA lists 6 510(k) clearances under the applicant name “Biotrine Corp.” (first 1981, latest 1992), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Biotrine Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biotrine Corp. is 57 days.
Which FDA product codes appear under Biotrine Corp.?
The most frequent FDA product codes under this applicant name are BZG (Spirometer, Diagnostic, 2); BZH (Meter, Peak Flow, Spirometry, 2); BTI (Compressor, Air, Portable, 1).
Next steps
- See all 6 Biotrine Corp. clearances with predicates and recalls
- Run predicate analysis for product code BZG, Biotrine Corp.'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.