Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Olson Medical Sales, 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) |
|---|---|---|---|---|---|
| K000977 | COMPONENTS FOR CARDIOVASCULAR PROCEDURE KIT - HEAT EXCHANGER | Olson Medical Sales, Inc. | 2001-03-23 | 361 | 1 |
| K993060 | GAS FILTER | Olson Medical Sales, Inc. | 2000-03-28 | 197 | 0 |
| K993062 | CHEST DRAINAGE TUBING | Olson Medical Sales, Inc. | 1999-12-10 | 88 | 0 |
| K992906 | COMPONENTS FOR CARDIOVASCULAR PROCEDURE KIT | Olson Medical Sales, Inc. | 1999-11-10 | 72 | 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