Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Prestige Ameritech — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
117 daysmedian FDA review time
449 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K231741 | ProGear® Surgical Mask with Oxafence®, Model AV82030 | Prestige Ameritech | 2024-09-05 | 449 | 0 |
| K171162 | Surgical Earloop Face Mask with Bottom Gap Shield and Surgic | Prestige Ameritech | 2017-08-15 | 117 | 0 |
| K160100 | Prestige Ameritech Pediatric/Child’s Face mask | Prestige Ameritech | 2016-10-07 | 262 | 0 |
| K102092 | PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, | Prestige Ameritech | 2010-10-06 | 71 | 0 |
| K061716 | PRESTIGE AMERITECH FACE MASK | Prestige Ameritech | 2006-08-14 | 56 | 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