Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
The Olympus Optical Co. — Predicate Candidate Screening
22 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
74 daysmedian FDA review time
243 days90th percentile
22clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K032066 | SONOSURG SYSTEM | The Olympus Optical Co. | 2003-10-03 | 92 | 0 |
| K030194 | XUES-41 ENDOSCOPIC ELECTROSURGICAL UNIT | The Olympus Optical Co. | 2003-03-24 | 62 | 3 |
| K021962 | OLYMPUS ULTRASONIC SURGICAL SYSTEM | The Olympus Optical Co. | 2003-02-12 | 243 | 0 |
| K023984 | MODIFICATION TO OLYMPUS BRONCHOSCOPES BF-40 SERIES, BF-240 S | The Olympus Optical Co. | 2003-01-31 | 60 | 16 |
| K023272 | DISPOSABLE ASPIRATION NEEDLE NA-200H | The Olympus Optical Co. | 2002-12-23 | 83 | 0 |
| K023767 | UES-30 ELECTROSURGICAL UNIT AND IT'S ASSOCIATED ACCESSORIES | The Olympus Optical Co. | 2002-11-29 | 17 | 0 |
| K012074 | XBO1-824-18/19/20 BIOPSY FORCEPS | The Olympus Optical Co. | 2001-09-25 | 85 | 0 |
| K012073 | OLYMPUS SPRAY CATHETER PW-6C-1 | The Olympus Optical Co. | 2001-08-10 | 39 | 0 |
| K011869 | XENF-DP RHINO-LARYNGOFIBERSCOPE, ITS ACCESSORIES AND ANCILLA | The Olympus Optical Co. | 2001-07-25 | 41 | 0 |
| K011151 | EVIS EXERA GASTROINTESTINAL VIDEOSCOPE GIF-Q160Z | The Olympus Optical Co. | 2001-05-15 | 29 | 1 |
| K011149 | DISPOSABLE BENDING CANNULA PR-233Q | The Olympus Optical Co. | 2001-05-15 | 29 | 0 |
| K002749 | ENDOSCOPE CONTOUR DETECTION DEVICE, MODEL 3DX45 AND COLONOSC | The Olympus Optical Co. | 2000-12-04 | 90 | 0 |
| K000095 | OLYMPUS SONOSURG TROCAR XT3900 SYSTEM | The Olympus Optical Co. | 2000-09-26 | 257 | 0 |
| K001203 | OLYMPUS UM 2R/3R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY E | The Olympus Optical Co. | 2000-05-26 | 43 | 0 |
| K001241 | EVIS EXERA COLONOVIDEOSCOPE CF-Q160 AL/I AND PCF-160 AL/I | The Olympus Optical Co. | 2000-05-09 | 21 | 1 |
| K993041 | OLYMPUS XCYF-1T3 OES CYSTOFIBERSCOPE/NEPHROFIBERSCOPE ACCESS | The Olympus Optical Co. | 2000-03-30 | 202 | 0 |
| K982733 | OLYMPUS MH-246R BALLOON SHEATH, FOR BRONCHIAL USE | The Olympus Optical Co. | 1998-10-28 | 84 | 0 |
| K982133 | OLYMPUS ENDOSCOPIC SYSTEM LUMBAR HERNIA DISCECTOMY AND ITS A | The Olympus Optical Co. | 1998-10-22 | 127 | 0 |
| K982734 | OLYMPUS MH-246R BALLOON SHEATH, FOR URINARY TRACT USE | The Olympus Optical Co. | 1998-10-05 | 61 | 0 |
| K981993 | OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA | The Olympus Optical Co. | 1998-08-21 | 74 | 0 |
| K981543 | OLYMPUS LF-TP AND LF-DP TRACHEAL INTUBATION FIBERSCOPES, ACC | The Olympus Optical Co. | 1998-06-08 | 39 | 5 |
| K972114 | OLYMPUS SONOSURG SYSTEM | The Olympus Optical Co. | 1998-05-18 | 347 | 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