Cleared Traditional

K931442 - 11274 AB FLEXIBLE PEDIATRIC BRONCHOSCOPE

K931442 is the FDA 510(k) clearance for 11274 AB FLEXIBLE PEDIATRIC BRONCHOSCOPE by KARL STORZ Endoscopy-America, Inc.. It is a Class 2 Ear, Nose, Throat device (product code EOQ) cleared through the Traditional 510(k) pathway after a 673-day FDA review.

K931442 · KARL STORZ Endoscopy-America, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1995
Decision
673d
Days
Class 2
Risk

K931442 is an FDA 510(k) clearance for the 11274 AB FLEXIBLE PEDIATRIC BRONCHOSCOPE. Classified as Bronchoscope (flexible Or Rigid) (product code EOQ), Class II - Special Controls.

Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on January 24, 1995 after a review of 673 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 KARL STORZ Endoscopy-America, Inc. devices

Submission Details

510(k) Number K931442 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 1993
Decision Date January 24, 1995
Days to Decision 673 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
584d slower than avg
Panel avg: 89d · This submission: 673d
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 182
Devices cleared under the same product code (EOQ) and FDA review panel - the closest regulatory comparables to K931442.
RITE-BITE BIOPSY FORCEPS
K951051 · Mill-Rose Laboratory · Mar 1995
OLYMPUS BIOPSY FORCEPS MODEL FB-44
K950786 · Olympus America, Inc. · Mar 1995
OLYMPUS DISPOSABLE BIOPSY FORCEPS
K950636 · Olympus America, Inc. · Feb 1995
MILL-ROSE HARRELL BRONCHIAL BRUSH
K944649 · Mill-Rose Laboratory · Nov 1994
WANG BRONCHIAL NEEDLE BRUSH
K944650 · Mill-Rose Laboratory · Nov 1994
KARL STORZ BRONCHOSCOPE ACCESSORIES
K943700 · KARL STORZ Endoscopy-America, Inc. · Aug 1994