Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Revivant Corp. — 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) |
|---|---|---|---|---|---|
| K040453 | AUTOPULSE RESUSCITATION SYSTEM, MODEL 100 | Revivant Corp. | 2004-03-11 | 17 | 2 |
| K032852 | MODIFICATION TO: AUTOPULSE RESUSCITATION SYSTEM MODEL 100 | Revivant Corp. | 2003-11-12 | 61 | 2 |
| K022345 | AUTOPULSE RESUSCITATION SYSTEM | Revivant Corp. | 2002-08-15 | 27 | 2 |
| K011046 | AUTOPULSE, MODEL 100 | Revivant Corp. | 2001-10-25 | 202 | 2 |
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