510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K021204Substantially Equivalent

Olympus Bf Type Um40

Olympus Optical Co., Ltd., Melville NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K021204 is the FDA 510(k) clearance record for OLYMPUS BF TYPE UM40, a class II device, cleared for Olympus Optical Co., Ltd. on under FDA product code PSV (Ultrasound Bronchoscope). FDA's definition for product code PSV reads: "An ultrasound bronchoscope is indicated for the ultrasonic visualization, diagnosis and therapeutic access to the bronchial tree or the lungs. If the device is reusable, validated reprocessing instructions and reprocessing validation data...". FDA records list 48 510(k) clearances for Olympus Optical Co., Ltd., from to . As of , FDA records show no recalls naming K021204.

Clearance record

Decision date
Received
(15 days to decision)
Product code
PSV Ultrasound Bronchoscope
Regulation
21 CFR 892.1550
Device class
Class II
Review panel
Radiology
Applicant
Olympus Optical Co., Ltd. Two Corporate Center Dr., Melville NY
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code PSV

Trailing 12 months
1 clearance under product code PSV in the twelve months to October 2026, August 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code PSV, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260