Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FZH · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K923233 | CARDIO-PAK LAPAROTOMY PACK | Cardio-Med-Associates, Inc. | 1993-03-20 | 262 | 1 |
| K875305 | MODEL UCA / SPEC SYSTEM UCA | Spec Systems, Inc. | 1988-01-27 | 29 | 0 |
| K871901 | ULTRAFLOW | Custom Industries, Inc. | 1987-06-01 | 17 | 0 |
| K770084 | OPERATING ROOM VENTILATOR | Dupaco, Inc. | 1977-02-23 | 40 | 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