Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Healthdyne Cardiovascular, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
119 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K901643 | ISOFLO(TM) AMNIOCENTESIS TRAY | Healthdyne Cardiovascular, Inc. | 1990-07-25 | 107 | 0 |
| K901382 | ISOFLO(TM) HIGH PRESSURE INJECTION LINES | Healthdyne Cardiovascular, Inc. | 1990-07-19 | 119 | 0 |
| K901084 | ISOFLO INTRAUTERINE PRESSURE MONITORING & AMNIO. | Healthdyne Cardiovascular, Inc. | 1990-06-01 | 86 | 0 |
| K900665 | DRESSING CHANGE KIT | Healthdyne Cardiovascular, Inc. | 1990-05-14 | 90 | 0 |
| K895763 | ISOFLO AND ISOTEC INTRAUTERINE PRESSURE MONITORING | Healthdyne Cardiovascular, Inc. | 1989-12-22 | 87 | 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