Cleared Traditional

K922204 - MILL-ROSE PULMONARY FORCEPS

K922204 is the FDA 510(k) clearance for MILL-ROSE PULMONARY FORCEPS 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 428-day FDA review.

K922204 · Mill-Rose Laboratory · Ear, Nose, Throat device
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Jul 1993
Decision
428d
Days
Class 2
Risk

K922204 is an FDA 510(k) clearance for the MILL-ROSE PULMONARY FORCEPS. 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 July 13, 1993 after a review of 428 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Ear, Nose, Throat submissions.

View all Mill-Rose Laboratory devices

Submission Details

510(k) Number K922204 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1992
Decision Date July 13, 1993
Days to Decision 428 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
339d slower than avg
Panel avg: 89d · This submission: 428d
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 K922204.
MILL-ROSE PROTECTED TRANSLARYNGOSCOPIC CATHETER
K940521 · Mill-Rose Laboratory · May 1994
VB-1830/VB-1530, VIDEO BRONCHOSCOPE
K934920 · Pentax Precision Instrument Corp. · Jan 1994
EVIS 200 SYSTEM
K931154 · Olympus Corp. · Oct 1993
DISPOSABLE BRONCHOSCOPE BIOPSY FORCEPS
K923847 · Wilson-Cook Medical, Inc. · Nov 1992
OLYMPUS DISPOSABLE SUCTION VALVE
K920025 · Olympus Corp. · Mar 1992
WANG/MILL-ROSE TRANSBRONCHIAL ASPIRATION NEEDLE
K914181 · Mill-Rose Laboratory · Dec 1991