Cleared Traditional

K854414 - DUMON/HARRELL

K854414 is the FDA 510(k) clearance for DUMON/HARRELL by Bryan Corp.. It is a Class 2 Ear, Nose, Throat device (product code EOQ) cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K854414 · Bryan Corp. · Ear, Nose, Throat device
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Mar 1986
Decision
128d
Days
Class 2
Risk

K854414 is an FDA 510(k) clearance for the DUMON/HARRELL. Classified as Bronchoscope (flexible Or Rigid) (product code EOQ), Class II - Special Controls.

Submitted by Bryan Corp. (Woburn, US). The FDA issued a Cleared decision on March 12, 1986 after a review of 128 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Bryan Corp. devices

Submission Details

510(k) Number K854414 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1985
Decision Date March 12, 1986
Days to Decision 128 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 89d · This submission: 128d
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 183
Devices cleared under the same product code (EOQ) and FDA review panel - the closest regulatory comparables to K854414.
BIOPSY FORCEPS
K895415 · Symbiosis Corp. · Oct 1989
CANNULATED BIOPSY FORCEPS
K892687 · Zinnanti Surgical Instruments, Inc. · Jun 1989
CO2 FIBEROPTIC DELIVERY SYSTEM/BRONCHOSCOPIC USE
K862835 · Cooper Lasersonics, Inc. · Feb 1987
LARYNGOTELESCOPE CURVED MLC-1
K832449 · Pentax Precision Instrument Corp. · Sep 1983
BRONCHO FIBERSCOPE FB-19C
K832492 · Pentax Precision Instrument Corp. · Sep 1983
BRONCHO-FIBERSCOPE
K832010 · KARL STORZ Endoscopy-America, Inc. · Aug 1983