Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Heartlab, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
85 daysmedian FDA review time
148 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K050858 | ASCENTIA HEARTSTATION ECG MANAGEMENT SYSTEM | Heartlab, Inc. | 2005-06-29 | 85 | 1 |
| K050228 | AGFA HEARTLAB CARDIOVASCULAR | Heartlab, Inc. | 2005-02-18 | 17 | 20 |
| K042042 | ULTRASOUND CAPTURE SYSTEM | Heartlab, Inc. | 2004-09-21 | 54 | 0 |
| K040896 | MODIFICATION TO ENCOMPASS | Heartlab, Inc. | 2004-07-16 | 101 | 1 |
| K954479 | DICOMVIEW | Heartlab, Inc. | 1996-02-21 | 148 | 0 |
| K954860 | ECHONET | Heartlab, Inc. | 1995-12-21 | 59 | 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