EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XP190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-P190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XT190); BRONCHOVIDEOSCOPE (OLYMPUS BF-H1100); BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH1100)
FDA 510(k) clearance K250862 · decided 2025-06-23
Clearance details
- K-number
- K250862
- Device name
- EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XP190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-P190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XT190); BRONCHOVIDEOSCOPE (OLYMPUS BF-H1100); BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH1100)
- Applicant
- Olympus Medical Systems Corp.
- Decision
- Substantially Equivalent
- Date received
- 2025-03-21
- Decision date
- 2025-06-23
- Days to decision
- 94 days
- Clearance type
- Traditional
- Product code
- EOQ
- Device class
- 2
- Regulation number
- 874.4680
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Tokyo, JP
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Olympus Medical Systems Corp.
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| BRONCHOVIDEOSCOPE OLYMPUS BF-1TH1100 recall (Z-0048-2026) | Olympus Corporation of the Americas | 2025-10-16 |
| BRONCHOVIDEOSCOPE OLYMPUS BF-H1100 recall (Z-0052-2026) | Olympus Corporation of the Americas | 2025-10-16 |
| EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-P190 recall (Z-0057-2026) | Olympus Corporation of the Americas | 2025-10-16 |
| EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS BF-XT190 recall (Z-0066-2026) | Olympus Corporation of the Americas | 2025-10-16 |