Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Olsen Medical · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
189 daysmedian FDA review time
384 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K130669 | SINGLE USE & MULTI USE BIPOLAR FORCEPS / SINGLE USE & MULTI | Olsen Medical | 2013-12-06 | 269 | 0 |
| K111262 | ELECTROSURGICAL MONOPOLAR CABLE/ADAPTERS, ELECTROSURGICAL BI | Olsen Medical | 2012-05-23 | 384 | 0 |
| K080187 | OLSEN MEDICAL SINGLE USE BAYONET BIPOLAR IRRIGATING FORCEPS | Olsen Medical | 2008-05-09 | 105 | 0 |
| K072937 | OLSEN MEDICAL INTEGRATED IRRIGATION TUBING AND BIPOLAR CORD | Olsen Medical | 2007-12-28 | 73 | 0 |
| K042073 | OLSEN MEDICAL ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM | Olsen Medical | 2005-02-07 | 189 | 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