Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biotex, Inc. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
119 daysmedian FDA review time
216 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233442 | troCarWash™ System | Biotex, Inc. | 2024-05-21 | 216 | 0 |
| K222695 | troCarWash™ System | Biotex, Inc. | 2023-02-17 | 164 | 0 |
| K203712 | The Slide | Biotex, Inc. | 2021-07-20 | 211 | 0 |
| K161704 | Phasor Drill | Biotex, Inc. | 2016-12-01 | 164 | 1 |
| K092197 | PHOTEX30 DIODE LASER SERIES: 980, 810, 940 | Biotex, Inc. | 2009-10-06 | 77 | 0 |
| K081656 | VISUALASE THERMAL THERAPY SYSTEM | Biotex, Inc. | 2008-09-10 | 90 | 0 |
| K071328 | VISUALASE THERMAL THERAPY SYSTEM | Biotex, Inc. | 2007-08-31 | 112 | 0 |
| K063505 | VISUALASE ENVISION SOFTWARE SYSTEM | Biotex, Inc. | 2006-12-12 | 22 | 0 |
| K060304 | PHOTEX DIODE LASER SERIES, MODELS 980, 810 AND 940 | Biotex, Inc. | 2006-03-21 | 43 | 0 |
| K053087 | VISUALASE COOLED LASER APPLICATOR SYSTEM, LASER DIFFUSING FI | Biotex, Inc. | 2006-03-01 | 119 | 3 |
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