Cleared Traditional

K021204 - OLYMPUS BF TYPE UM40 (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K021204 · Olympus Optical Co., Ltd. · Radiology device
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Optimized for regulatory review, auditing and printing
May 2002
Decision
15d
Days
Class 2
Risk

K021204 is an FDA 510(k) clearance for the OLYMPUS BF TYPE UM40. Classified as Ultrasound Bronchoscope (product code PSV), Class II - Special Controls.

Submitted by Olympus Optical Co., Ltd. (Melville, US). The FDA issued a Cleared decision on May 1, 2002 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1550 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Olympus Optical Co., Ltd. devices

Submission Details

510(k) Number K021204 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2002
Decision Date May 01, 2002
Days to Decision 15 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 107d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code PSV Ultrasound Bronchoscope
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1550
Definition 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 For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.