Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Apex Medical Technologies, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
246 daysmedian FDA review time
1064 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K112165 | RHEA CUP | Apex Medical Technologies, Inc. | 2012-05-24 | 301 | 0 |
| K060933 | SOLACE POST-OPERATIVE PAIN RELIEF INFUSION SYSTEM | Apex Medical Technologies, Inc. | 2006-05-09 | 34 | 0 |
| K954791 | SEMINAL FLUID COLLECTION KIT II | Apex Medical Technologies, Inc. | 1996-01-05 | 79 | 0 |
| K922688 | EXTRA PROTECTION POLYURETHANE CONDOM | Apex Medical Technologies, Inc. | 1995-05-04 | 1064 | 0 |
| K930313 | APEX SPECIMEN BAG | Apex Medical Technologies, Inc. | 1993-03-18 | 55 | 0 |
| K902936 | POLYURETHANE CONDOM | Apex Medical Technologies, Inc. | 1991-03-06 | 246 | 0 |
| K871358 | SENSATIONS BRAND CONDOMS | Apex Medical Technologies, Inc. | 1989-03-01 | 695 | 0 |
| K874539 | HI-TOUCH (TM) BRAND SURGICAL GLOVES | Apex Medical Technologies, Inc. | 1987-12-14 | 41 | 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