Cleared Traditional

OLYMPUS DISPOSABLE SUCTION VALVE (K920025) - FDA 510(k) Clearance

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K920025 · Olympus Corp. · Ear, Nose, Throat device
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Mar 1992
Decision
81d
Days
Class 2
Risk

K920025 is an FDA 510(k) clearance for the OLYMPUS DISPOSABLE SUCTION VALVE. Classified as Bronchoscope (flexible Or Rigid) (product code EOQ), Class II - Special Controls.

Submitted by Olympus Corp. (Lake Success, US). The FDA issued a Cleared decision on March 24, 1992 after a review of 81 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4680 - the FDA ear, nose and throat device 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 Corp. devices

Submission Details

510(k) Number K920025 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 1992
Decision Date March 24, 1992
Days to Decision 81 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 89d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EOQ Bronchoscope (flexible Or Rigid)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.4680
Definition A Bronchoscope (flexible Or Rigid) And Accessories Is A Tubular Endoscopic Device With Any Of A Group Of Accessory Devices Which Attach To The Bronchoscope And Is Intended To Examine Or Treat The Larynx And Tracheobronchial Tree. If The Device Is Reprocessed, Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission. 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 Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - EOQ Bronchoscope (flexible Or Rigid)

All 133
Devices cleared under the same product code (EOQ) and FDA review panel - the closest regulatory comparables to K920025.
11274 AB FLEXIBLE PEDIATRIC BRONCHOSCOPE
K931442 · KARL STORZ Endoscopy-America, Inc. · Jan 1995
KARL STORZ BRONCHOSCOPE ACCESSORIES
K943700 · KARL STORZ Endoscopy-America, Inc. · Aug 1994
EVIS 200 SYSTEM
K931154 · Olympus Corp. · Oct 1993
OLYMPUS DISPOSABLE BIOPSY VALVE
K911412 · Olympus Corp. · Jun 1991
BRONCHOSCOPE BF-N20
K910423 · Olympus Corp. · Apr 1991
BRONCHO-FIBERSCOPE
K832010 · KARL STORZ Endoscopy-America, Inc. · Aug 1983