Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Zargis Medical Corp. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
95 daysmedian FDA review time
377 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K090493 | SIGNAL | Zargis Medical Corp. | 2009-08-07 | 163 | 0 |
| K083309 | ZARGIS ACOUSTIC CARDIOSCAN, VERSION 9.33 | Zargis Medical Corp. | 2009-02-13 | 95 | 0 |
| K060197 | ZARGIS ACOUSTIC CARDIOSCAN (ZAC), MODEL ZAC 6.28 | Zargis Medical Corp. | 2006-03-29 | 62 | 0 |
| K042128 | MODIFICATION TO ZARGIS ACOUSTIC CARDIOSCAN (ZAC) | Zargis Medical Corp. | 2004-09-08 | 33 | 0 |
| K031517 | ZARGIS ACOUSTIC CARDIOSCAN | Zargis Medical Corp. | 2004-05-26 | 377 | 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