Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Avail-Southwest Division · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K952678 | STA-CLEAR ALCOHOL-FREE ENDOSCOPIC ANTI-FOG KIT | Avail-Southwest Division | 1995-07-10 | 28 | 0 |
| K950830 | STA-PUT NON-MAGNETIC INSTRUMENT DRAPE CATALOG #100-187-00 (1 | Avail-Southwest Division | 1995-05-03 | 68 | 0 |
| K933520 | ENDOSCOPIC ANTI-FOG KIT, 100-302-00 | Avail-Southwest Division | 1993-08-24 | 35 | 0 |
| K864158 | THERMAPAD | Avail-Southwest Division | 1987-03-02 | 130 | 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