Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FHF · Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K093479 | DISPOSABLE SUCTION AND IRRIGATION SYSTEM | Modern Medical Equipment Mfg., Ltd. | 2010-05-19 | 191 | 0 |
| K003443 | SUCTION IRRIGATOR | Applied Medical | 2001-02-01 | 87 | 0 |
| K771986 | CATHETER, MEDIASTINAL&PERICARDIAL | The Minnesota Back Brace Co. | 1977-10-28 | 9 | 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