Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Olympus Medical Systems Corporation · Predicate Candidate Screening
83 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
108 daysmedian FDA review time
258 days90th percentile
83clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261183 | EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF- | Olympus Medical Systems Corporation | 2026-07-31 | 112 | 0 |
| K261260 | HD Camera Head OLYMPUS CH-S200-08-LB | Olympus Medical Systems Corporation | 2026-06-24 | 69 | 0 |
| K252050 | Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D | Olympus Medical Systems Corporation | 2026-03-20 | 262 | 0 |
| K250993 | Single Use Cytology Brush V (BC-V600P-3010) | Olympus Medical Systems Corporation | 2025-12-18 | 262 | 0 |
| K252889 | Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M) | Olympus Medical Systems Corporation | 2025-11-25 | 76 | 0 |
| K250409 | Disposable Balloon Catheter (B5-2Q); Disposable Balloon Cath | Olympus Medical Systems Corporation | 2025-10-21 | 250 | 0 |
| K252247 | Injector Force Max Single Use Injector (NM-400L); Injector F | Olympus Medical Systems Corporation | 2025-10-16 | 90 | 0 |
| K250351 | Single Use Electrosurgical Knife (KD-612L, KD-612U); Single | Olympus Medical Systems Corporation | 2025-10-10 | 245 | 0 |
| K250187 | Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biop | Olympus Medical Systems Corporation | 2025-10-07 | 258 | 0 |
| K252150 | Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless T | Olympus Medical Systems Corporation | 2025-10-07 | 90 | 4 |
| K251859 | EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF- | Olympus Medical Systems Corporation | 2025-10-03 | 108 | 0 |
| K251986 | AUXILIARY WATER TUBE MAJ-855 | Olympus Medical Systems Corporation | 2025-09-26 | 91 | 0 |
| K251997 | Single-Use Biopsy Valve (MAJ-1555) | Olympus Medical Systems Corporation | 2025-09-25 | 90 | 0 |
| K250883 | ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R | Olympus Medical Systems Corporation | 2025-09-18 | 178 | 0 |
| K251664 | Single Use Aspiration Needle (NA-201SX-4021); Single Use Asp | Olympus Medical Systems Corporation | 2025-07-29 | 60 | 0 |
| K250949 | Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444) | Olympus Medical Systems Corporation | 2025-07-16 | 110 | 2 |
| K250762 | ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE U | Olympus Medical Systems Corporation | 2025-07-11 | 120 | 0 |
| K251279 | Disposable Cytology Brush BC-202D/203D Series | Olympus Medical Systems Corporation | 2025-06-12 | 49 | 0 |
| K250118 | Disposable Balloon Catheter B5-2C | Olympus Medical Systems Corporation | 2025-06-04 | 139 | 0 |
| K250957 | Disposable Biopsy Forceps (FB-211D); Disposable Biopsy Force | Olympus Medical Systems Corporation | 2025-05-30 | 60 | 0 |
| K250432 | Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500D | Olympus Medical Systems Corporation | 2025-05-15 | 90 | 0 |
| K241842 | Luer-Split MAJ-2092 | Olympus Medical Systems Corporation | 2025-03-19 | 266 | 0 |
| K243380 | VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S | Olympus Medical Systems Corporation | 2025-03-03 | 124 | 0 |
| K243502 | EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME3 (OLYMPU | Olympus Medical Systems Corporation | 2025-01-17 | 66 | 0 |
| K243527 | High Flow Insufflation Unit (UHI-4) | Olympus Medical Systems Corporation | 2025-01-13 | 60 | 1 |
| K242357 | Water Container (MAJ-901); Water Container (MAJ-902) | Olympus Medical Systems Corporation | 2024-10-07 | 60 | 0 |
| K241371 | VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S | Olympus Medical Systems Corporation | 2024-07-03 | 49 | 0 |
| K232997 | EVIS Exera III Gastrointestinal Videoscope GIF-1TH190 | Olympus Medical Systems Corporation | 2024-06-19 | 271 | 2 |
| K222861 | EVIS XI Video System Center Olympus CV-1500, Bronchovideosco | Olympus Medical Systems Corporation | 2023-06-15 | 266 | 0 |
| K222584 | EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500, COLONOVIDEOSCOP | Olympus Medical Systems Corporation | 2023-04-26 | 243 | 1 |
| K221683 | CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2), CYSTO-NEPHRO VIDEO | Olympus Medical Systems Corporation | 2023-01-20 | 224 | 5 |
| K221557 | Visera Hysterovideoscope Olympus HYF Type V | Olympus Medical Systems Corporation | 2022-09-02 | 94 | 2 |
| K211838 | Ultrasonic Bipolar Generator USG-410 with accessories | Olympus Medical Systems Corporation | 2021-08-04 | 51 | 13 |
| K123317 | EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIXP190N | Olympus Medical Systems Corporation | 2012-12-11 | 47 | 0 |
| K122180 | HIGH FLOW INSUFFLANTION UNIT | Olympus Medical Systems Corporation | 2012-11-13 | 113 | 1 |
| K112680 | EVIS EXERA III VIDEO SYSTEM | Olympus Medical Systems Corporation | 2012-02-16 | 155 | 6 |
| K110294 | HIGH FLOW INSUFFLATION UNIT UHI-4 | Olympus Medical Systems Corporation | 2011-11-18 | 290 | 2 |
| K103312 | UPD-Y0003 | Olympus Medical Systems Corporation | 2011-05-12 | 183 | 0 |
| K103478 | SINGLE USE BILIARY DRAINAGE STENT V | Olympus Medical Systems Corporation | 2011-02-24 | 90 | 0 |
| K103264 | ENDOSCOPE REPROCESSOR OER-PRO MODEL OER-PRO | Olympus Medical Systems Corporation | 2011-02-23 | 111 | 6 |
| K102763 | SYSTEMS INTEGRATION | Olympus Medical Systems Corporation | 2011-02-15 | 144 | 0 |
| K102379 | LTF-Y0009; MAJ-YOO41; XOEV-3D1 | Olympus Medical Systems Corporation | 2011-01-05 | 135 | 0 |
| K102059 | AUTOCLAVABLE CAMER HEAD MODEL OTV-Y0017 | Olympus Medical Systems Corporation | 2010-10-08 | 78 | 0 |
| K101053 | OLYMPUS CF TYPE Y0023-L, Y0023I | Olympus Medical Systems Corporation | 2010-07-14 | 90 | 0 |
| K100584 | EVIS EXERAII 180 SYSTEM | Olympus Medical Systems Corporation | 2010-07-02 | 122 | 7 |
| K093395 | OLYMPUS GF TYPE UC180, OLYMPUS GF TYPE UCT180 EVIS EXERA II | Olympus Medical Systems Corporation | 2010-06-17 | 230 | 2 |
| K100345 | SYSTEMS INTEGRATION MODEL: ENDOALPHA | Olympus Medical Systems Corporation | 2010-03-22 | 45 | 0 |
| K093507 | OLYMPUS CHF TYPE Y0003 | Olympus Medical Systems Corporation | 2010-03-10 | 117 | 1 |
| K093106 | ENDOSCOPE REPROCESSOR OER-PRO | Olympus Medical Systems Corporation | 2010-02-12 | 134 | 0 |
| K092309 | SINGLE USE ELECTROSURGICAL KNIFE SERIES, MODEL KD-610L, KD-6 | Olympus Medical Systems Corporation | 2009-10-30 | 92 | 1 |
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