Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Heartware Intl. 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) |
|---|---|---|---|---|---|
| K932410 | HEARTVIEW(R) CORONARY ANGIOGRAPH DIAGRAM/REPORT SY | Heartware Intl. Corp. | 1993-12-13 | 209 | 0 |
| K933073 | HEARTTRACE LEFT VENTRICULAR ANALYSIS SOFTWARE | Heartware Intl. Corp. | 1993-10-07 | 106 | 0 |
| K933058 | HEARTTRACK QUANTITATIVE CORONARY ANGIOGRAPHY SOFTW | Heartware Intl. Corp. | 1993-09-28 | 98 | 0 |
| K893094 | HB 1000, BRUGADA ELECTROPHYSIOLOGY SYSTEM | Heartware Intl. Corp. | 1989-10-02 | 157 | 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