Biotron , Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Biotron , Ltd.” (first 1978, latest 1991), across 4 product codes in 4 review panels. Median 510(k) review time under this name: 55 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 |
|---|---|---|---|
| IPF | Stimulator, Muscle, Powered | 2 | 2 |
| JJW | Urinalysis Controls (Assayed And Unassayed) | 1 | 1 |
| JXA | Kit, Screening, Urine | 1 | 1 |
| LZN | Cement Obturator | 1 | 1 |
Review panels
- Physical Medicine (2)
- Clinical Chemistry (1)
- Microbiology (1)
- Orthopedic (1)
Most recent Biotron , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K910135 | THE UNIVERSAL CEMENT PLUG(TM) | LZN | 1991-03-05 | 55 |
| K843583 | FIRM-A-TRON MARK X | IPF | 1984-11-29 | 79 |
| K810634 | FIRM-A-TRON | IPF | 1981-06-12 | 94 |
| K780802 | ARMTROL AND FERMTROL | JJW | 1978-06-13 | 33 |
| K780803 | TILL-U-TEST, DIP SLIDE | JXA | 1978-06-06 | 26 |
Recalls
openFDA lists no recalls under a recalling firm named Biotron , Ltd..
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Biotron U.S.A., Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Biotron , Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Biotron , Ltd.” (first 1978, latest 1991), across 4 product codes in 4 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 Biotron , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biotron , Ltd. is 55 days.
Which FDA product codes appear under Biotron , Ltd.?
The most frequent FDA product codes under this applicant name are IPF (Stimulator, Muscle, Powered, 2); JJW (Urinalysis Controls (Assayed And Unassayed), 1); JXA (Kit, Screening, Urine, 1).
Next steps
- See all 5 Biotron , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code IPF, Biotron , Ltd.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.