Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Olympus Medical Systems Corp. · Predicate Candidate Screening
103 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
147 daysmedian FDA review time
280 days90th percentile
103clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K254056 | THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545 | Olympus Medical Systems Corp. | 2026-07-01 | 196 | 0 |
| K260580 | Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); | Olympus Medical Systems Corp. | 2026-05-21 | 90 | 0 |
| K252341 | EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXE | Olympus Medical Systems Corp. | 2026-04-23 | 269 | 0 |
| K251807 | Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-4 | Olympus Medical Systems Corp. | 2026-03-06 | 267 | 0 |
| K253646 | Single Use Distal Cover MAJ-2315 (MAJ-2315) | Olympus Medical Systems Corp. | 2026-02-22 | 94 | 0 |
| K251336 | VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S | Olympus Medical Systems Corp. | 2025-11-12 | 196 | 0 |
| K252646 | Single-Use Fine Needle Biopsy (FNB) device (NA-U210H) | Olympus Medical Systems Corp. | 2025-10-24 | 64 | 0 |
| K250945 | Single Use Preloaded Sphincterotome V (Distal Wire Guided) ( | Olympus Medical Systems Corp. | 2025-10-17 | 203 | 16 |
| K251867 | EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (TJF-Q190 | Olympus Medical Systems Corp. | 2025-09-19 | 94 | 1 |
| K250862 | EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XP190); EVIS EX | Olympus Medical Systems Corp. | 2025-06-23 | 94 | 4 |
| K250701 | Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190 | Olympus Medical Systems Corp. | 2025-06-05 | 90 | 0 |
| K250573 | Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/ | Olympus Medical Systems Corp. | 2025-05-27 | 90 | 0 |
| K250296 | Disposable Distal Attachment D-201 Series | Olympus Medical Systems Corp. | 2025-05-01 | 90 | 0 |
| K250263 | Disposable Grasping Forceps FG-52D/FG-54D | Olympus Medical Systems Corp. | 2025-03-31 | 61 | 0 |
| K243807 | Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432P | Olympus Medical Systems Corp. | 2025-03-18 | 97 | 0 |
| K240617 | Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); | Olympus Medical Systems Corp. | 2024-06-03 | 90 | 0 |
| K221690 | OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5), OES CYSTONEPHRO | Olympus Medical Systems Corp. | 2022-12-29 | 202 | 3 |
| K221660 | RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE-XP | Olympus Medical Systems Corp. | 2022-12-28 | 203 | 1 |
| K221631 | Tracheal Intubation Fiberscope OLYMPUS LF-P, VISERA Tracheal | Olympus Medical Systems Corp. | 2022-09-26 | 112 | 4 |
| K221638 | Rhino-Laryngo Videoscope Olympus ENF-VH, Rhino-Laryngo Video | Olympus Medical Systems Corp. | 2022-09-19 | 105 | 0 |
| K220587 | Evis Exera III Duodenovideoscope Olympus TJF-Q190V | Olympus Medical Systems Corp. | 2022-05-11 | 71 | 4 |
| K220069 | 4K UHD LCD Monitor OEV321UH | Olympus Medical Systems Corp. | 2022-03-09 | 58 | 1 |
| K212667 | Single Use Guide Sheath Kit-401, K-402 | Olympus Medical Systems Corp. | 2021-09-22 | 30 | 0 |
| K201832 | Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5 | Olympus Medical Systems Corp. | 2021-09-17 | 442 | 1 |
| K201300 | Airway Mobilescope | Olympus Medical Systems Corp. | 2021-01-26 | 256 | 2 |
| K201758 | EVIS EXERA III Bronchovideoscope Olympus BF-XP190, EVIS EXER | Olympus Medical Systems Corp. | 2021-01-21 | 206 | 5 |
| K200342 | Single Use Grasping Forceps FG-214P, Single Use Grasping For | Olympus Medical Systems Corp. | 2020-12-17 | 310 | 0 |
| K202661 | Evis Exera III Duodenovideoscope Olympus TJF-Q190V | Olympus Medical Systems Corp. | 2020-12-08 | 85 | 1 |
| K203128 | EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2/EVIS EU | Olympus Medical Systems Corp. | 2020-11-09 | 21 | 0 |
| K202646 | Visera Elite II Video System Center | Olympus Medical Systems Corp. | 2020-10-29 | 48 | 0 |
| K201920 | Endoscope Reprocessor OER-Elite | Olympus Medical Systems Corp. | 2020-09-01 | 53 | 15 |
| K201200 | Visera Elite II Video System Center | Olympus Medical Systems Corp. | 2020-07-22 | 79 | 0 |
| K200542 | Visera Elite II Xenon Light Source, Telescope IR/Telescope U | Olympus Medical Systems Corp. | 2020-07-17 | 136 | 0 |
| K192793 | Evis Exera III Colonovideoscope Olympus PCF-H190TL, Evis Exe | Olympus Medical Systems Corp. | 2020-07-17 | 291 | 3 |
| K192103 | Thunderbeat Open Fine Jaw Type X Hand Instrument | Olympus Medical Systems Corp. | 2020-05-11 | 280 | 0 |
| K192498 | Single Use Injector | Olympus Medical Systems Corp. | 2020-04-28 | 230 | 0 |
| K200397 | Single Use Biopsy Forceps FB-456D | Olympus Medical Systems Corp. | 2020-04-24 | 66 | 0 |
| K193026 | Visera Elite II Video System Center, Visera Elite II Endoeye | Olympus Medical Systems Corp. | 2020-04-03 | 156 | 0 |
| K192164 | Single Use Guide Sheath Kit K-401, K-402, & Single Use Guidi | Olympus Medical Systems Corp. | 2020-03-06 | 210 | 0 |
| K193182 | Evis Exera III Duodenovideoscope Olympus TJF-Q190V | Olympus Medical Systems Corp. | 2020-01-17 | 60 | 3 |
| K193039 | Single Use Balloon Dilator V (with knife) | Olympus Medical Systems Corp. | 2019-12-17 | 47 | 0 |
| K190239 | Single Use Aspiration Needle | Olympus Medical Systems Corp. | 2019-12-10 | 307 | 0 |
| K190772 | SURGICAL MICROSCOPE SYSTEM ORBEYE with IR | Olympus Medical Systems Corp. | 2019-10-10 | 198 | 0 |
| K183416 | Rhino-Laryngo Videoscope Olympus ENF-VT3 | Olympus Medical Systems Corp. | 2019-09-06 | 270 | 1 |
| K183525 | EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F | Olympus Medical Systems Corp. | 2019-09-06 | 261 | 1 |
| K183419 | EVIS EXERA III Bronchovideoscope Olympus BF-XT190 | Olympus Medical Systems Corp. | 2019-09-05 | 269 | 3 |
| K190449 | Visera Elite II Video System Center, Visera Elite II HD 3CMO | Olympus Medical Systems Corp. | 2019-08-30 | 186 | 0 |
| K190293 | Single Use Cytology Brush BC-205D | Olympus Medical Systems Corp. | 2019-08-02 | 172 | 0 |
| K183590 | Single Use Reloadable Clip Applicator, Clip, Long Clip, Shor | Olympus Medical Systems Corp. | 2019-08-01 | 223 | 0 |
| K190969 | ENDOSCOPE REPROCESSOR OER-Elite | Olympus Medical Systems Corp. | 2019-07-09 | 88 | 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