Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Heartvista, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
185 daysmedian FDA review time
329 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K212233 | RTHawk, HeartVista Cardiac Package | Heartvista, Inc. | 2021-10-05 | 81 | 0 |
| K183274 | RTHawk, HeartVista Cardiac Package | Heartvista, Inc. | 2019-10-18 | 329 | 0 |
| K170090 | RTHawk, HeartVista Cardiac Package | Heartvista, Inc. | 2017-07-14 | 185 | 0 |
| K153740 | RTHawk, HeartVista Cardiac Package | Heartvista, Inc. | 2016-06-30 | 185 | 0 |
| K142997 | RTHawk, HeartVista Workstation with RTHawk | Heartvista, Inc. | 2014-12-17 | 68 | 0 |
| K133848 | RTHAWK, RTHAWK, OR HEARTVISTA WORKSTATION WITH RTHAWK | Heartvista, Inc. | 2014-06-25 | 189 | 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