Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Apex Medical, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
213 daysmedian FDA review time
387 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K933965 | APEX MEDICAL AIR PUMPS | Apex Medical, Inc. | 1994-03-17 | 213 | 0 |
| K902102 | COM-TENS: A NEUROSTIMULATOR | Apex Medical, Inc. | 1991-05-30 | 387 | 0 |
| K882816 | PULSAR EM | Apex Medical, Inc. | 1989-04-27 | 293 | 0 |
| K882468 | ELIMINATOR AIR FILTER | Apex Medical, Inc. | 1988-08-29 | 75 | 0 |
| K871570 | APEX ALPHA VACUUM PUMP | Apex Medical, Inc. | 1987-08-18 | 118 | 0 |
| K871384 | APEX SUCTION CURETTE | Apex Medical, Inc. | 1987-05-22 | 45 | 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