Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ivex Medical, Inc. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K893545 | IVEX MODEL NO. BP 3000 BREASTPUMP | Ivex Medical, Inc. | 1990-02-16 | 284 | 0 |
| K884563 | OXYGEN CONCENTRATOR W/CONCENTRATION 3LPM 93% +/-3% | Ivex Medical, Inc. | 1989-04-26 | 177 | 0 |
| K883837 | MIKADO AC 405 | Ivex Medical, Inc. | 1988-12-12 | 91 | 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