Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Nova Health Systems, Inc. — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K895477 | NOVA PILLOW | Nova Health Systems, Inc. | 1990-01-10 | 121 | 0 |
| K893713 | NOVA OXYGEN TENT | Nova Health Systems, Inc. | 1989-08-21 | 95 | 0 |
| K780502 | NOVA AIR FLOATATION SYSTEM | Nova Health Systems, Inc. | 1978-04-10 | 12 | 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