Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Creative Biomedics, Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K964939 | THE PORTABLE FAMILY - MEDI-FACTS DX1 PORTABLE LITE AND DX1 P | Creative Biomedics, Inc. | 1997-03-06 | 86 | 0 |
| K951227 | DX1 | Creative Biomedics, Inc. | 1995-08-11 | 144 | 0 |
| K951157 | DX1-PORTABLE | Creative Biomedics, Inc. | 1995-08-11 | 150 | 0 |
| K951410 | DISPOSABLE PULMONARY FUNCTION FILTER | Creative Biomedics, Inc. | 1995-04-24 | 28 | 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