Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Olsen Electrosurgical, Inc. — Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
28 daysmedian FDA review time
308 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K922154 | INSULATED SPECULUM W/ SMOKE EVACUATOR OPTION | Olsen Electrosurgical, Inc. | 1994-04-21 | 714 | 0 |
| K912611 | OLSEN LAPAROSCOPIC INSTR, DISPOSABLE, SINGLE USE | Olsen Electrosurgical, Inc. | 1992-04-15 | 308 | 0 |
| K913108 | TEFLON COATED ELECTRODES/ELECTRODES HANDLES | Olsen Electrosurgical, Inc. | 1991-12-23 | 164 | 0 |
| K912612 | SMOKE/ODOR EVACUATOR #757 | Olsen Electrosurgical, Inc. | 1991-11-01 | 142 | 0 |
| K885199 | #500 SERIES FORCEPS W/CUT/COAGULATE SWITCHES | Olsen Electrosurgical, Inc. | 1989-01-13 | 28 | 4 |
| K885200 | 600 & 900 SERIES ELECTRODES & 755 & 756 HANDLE | Olsen Electrosurgical, Inc. | 1989-01-13 | 28 | 0 |
| K884171 | #875 DISPOSABLE BIOPOLAR CABLE | Olsen Electrosurgical, Inc. | 1988-10-24 | 24 | 0 |
| K884174 | MODIFIED OLSEN 755/756 SWITCHPENS | Olsen Electrosurgical, Inc. | 1988-10-24 | 24 | 0 |
| K884172 | MODIFIED OLSEN #770 DISPOSABLE HOLSTER | Olsen Electrosurgical, Inc. | 1988-10-24 | 24 | 0 |
| K884173 | #920 DISPOSABLE TUR CABLE | Olsen Electrosurgical, Inc. | 1988-10-24 | 24 | 0 |
| K884175 | #820/821 BIPOLAR FORCEPS | Olsen Electrosurgical, Inc. | 1988-10-24 | 24 | 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