Cleared Traditional

K914181 - WANG/MILL-ROSE TRANSBRONCHIAL ASPIRATIO...

K914181 is the FDA 510(k) clearance for WANG/MILL-ROSE TRANSBRONCHIAL ASPIRATIO... by Mill-Rose Laboratory. It is a Class 2 Ear, Nose, Throat device (product code EOQ) cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K914181 · Mill-Rose Laboratory · Ear, Nose, Throat device
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Dec 1991
Decision
83d
Days
Class 2
Risk

K914181 is an FDA 510(k) clearance for the WANG/MILL-ROSE TRANSBRONCHIAL ASPIRATION NEEDLE. Classified as Bronchoscope (flexible Or Rigid) (product code EOQ), Class II - Special Controls.

Submitted by Mill-Rose Laboratory (Mentor, US). The FDA issued a Cleared decision on December 10, 1991 after a review of 83 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 Mill-Rose Laboratory devices

Submission Details

510(k) Number K914181 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 1991
Decision Date December 10, 1991
Days to Decision 83 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
6d faster than avg
Panel avg: 89d · This submission: 83d
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 177
Devices cleared under the same product code (EOQ) and FDA review panel - the closest regulatory comparables to K914181.
MILL-ROSE PULMONARY FORCEPS
K922204 · Mill-Rose Laboratory · Jul 1993
DISPOSABLE BRONCHOSCOPE BIOPSY FORCEPS
K923847 · Wilson-Cook Medical, Inc. · Nov 1992
OLYMPUS DISPOSABLE SUCTION VALVE
K920025 · Olympus Corp. · Mar 1992
PROTECTED BRONCHOALVEOLAR LAVAGE BALLOON CATHETER
K910536 · Mill-Rose Laboratory · Sep 1991
OLYMPUS DISPOSABLE BIOPSY VALVE
K911412 · Olympus Corp. · Jun 1991
BRONCHOSCOPE BF-N20
K910423 · Olympus Corp. · Apr 1991