Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Universal Medical, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
208 daysmedian FDA review time
387 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K083535 | HEARTRAK SMART ECAT | Universal Medical, Inc. | 2008-12-15 | 17 | 0 |
| K071130 | HEARTRAK AF | Universal Medical, Inc. | 2008-05-14 | 387 | 0 |
| K033451 | HEARTRAK SMART AT/HEARTRAK SMART2 | Universal Medical, Inc. | 2004-02-05 | 98 | 0 |
| K980624 | CARDIOSTATION | Universal Medical, Inc. | 1998-05-11 | 82 | 0 |
| K960499 | HEARTRAK XL | Universal Medical, Inc. | 1996-08-06 | 186 | 0 |
| K954495 | PACETRAK PLUS | Universal Medical, Inc. | 1996-04-22 | 208 | 0 |
| K943123 | PACETRAK | Universal Medical, Inc. | 1995-05-03 | 308 | 0 |
| K943124 | HEARTRAK | Universal Medical, Inc. | 1995-05-03 | 308 | 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