Cleared Traditional

K920025 - OLYMPUS DISPOSABLE SUCTION VALVE

K920025 is the FDA 510(k) clearance for OLYMPUS DISPOSABLE SUCTION VALVE by Olympus Corp.. It is a Class 2 Ear, Nose, Throat device (product code EOQ) cleared through the Traditional 510(k) pathway after a 81-day FDA review.

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 187
Devices cleared under the same product code (EOQ) and FDA review panel - the closest regulatory comparables to K920025.
MILL-ROSE PULMONARY FORCEPS
K922204 · Mill-Rose Laboratory · Jul 1993
CANNULATED BIOPSY FORCEPS
K926430 · Thomasville Medical Assoc. · Mar 1993
DISPOSABLE BRONCHOSCOPE BIOPSY FORCEPS
K923847 · Wilson-Cook Medical, Inc. · Nov 1992
WANG/MILL-ROSE TRANSBRONCHIAL ASPIRATION NEEDLE
K914181 · Mill-Rose Laboratory · Dec 1991
PROTECTED BRONCHOALVEOLAR LAVAGE BALLOON CATHETER
K910536 · Mill-Rose Laboratory · Sep 1991
OLYMPUS DISPOSABLE BIOPSY VALVE
K911412 · Olympus Corp. · Jun 1991