Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Columbia Medical & Surgical, 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) |
|---|---|---|---|---|---|
| K942725 | CMI VELVET TOUCH VACUUM EXTRACTOR | Columbia Medical & Surgical, Inc. | 1995-05-05 | 330 | 0 |
| K932128 | CMI E-Z FLO BULB P.N. 701 | Columbia Medical & Surgical, Inc. | 1994-04-07 | 339 | 0 |
| K914552 | CMI VACUUM PUMP | Columbia Medical & Surgical, Inc. | 1993-09-07 | 697 | 0 |
| K915763 | MODIFIED DISPOSABLE FETAL VACUUM | Columbia Medical & Surgical, Inc. | 1992-03-18 | 85 | 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