Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biotron , Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
55 daysmedian FDA review time
94 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K910135 | THE UNIVERSAL CEMENT PLUG(TM) | Biotron , Ltd. | 1991-03-05 | 55 | 0 |
| K843583 | FIRM-A-TRON MARK X | Biotron , Ltd. | 1984-11-29 | 79 | 0 |
| K810634 | FIRM-A-TRON | Biotron , Ltd. | 1981-06-12 | 94 | 0 |
| K780802 | ARMTROL AND FERMTROL | Biotron , Ltd. | 1978-06-13 | 33 | 0 |
| K780803 | TILL-U-TEST, DIP SLIDE | Biotron , Ltd. | 1978-06-06 | 26 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda