DeviceClearance

EVIS EXERA III BRONCHOVIDEOSCOPE (3 models)— 510(k) K252341

Substantially Equivalent

Olympus Medical Systems Corp.

FDA 510(k) clearance K252341 for EVIS EXERA III BRONCHOVIDEOSCOPE (3 models), Substantially Equivalent on 2026-04-23. Applicant: Olympus Medical Systems Corp.. Device class: 2.

Summary

Olympus Medical Systems' record names three EVIS EXERA III BRONCHOVIDEOSCOPE models: OLYMPUS BF-Q190, BF-H190, and BF-1TH190. All three are filed under product code EOQ (Bronchoscope (Flexible Or Rigid)), and the record doesn't say how they differ.

Class II, 21 CFR 874.4680. Ear, Nose, and Throat is both the classification panel and the review panel, and it came in as a Traditional 510(k).

Olympus Medical Systems filed from Tokyo, Japan. The decision came 269 calendar days after FDA received it (July 28, 2025 to April 23, 2026).

Clearance details

Device name as filed
EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190)
Applicant
Olympus Medical Systems Corp.
Product code
Product code EOQ
Device class
Class 2
Regulation
21 CFR 874.4680
Advisory panel
Ear, Nose, Throat
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Tokyo, JP
Download summary PDFView on FDA.gov ↗

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Adverse events under product code EOQ

product code EOQ
Death
135
Injury
2,863
Malfunction
21,662
Total
24,660

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.