Cleared Traditional

BRONCHOSCOPE (K954707) - FDA 510(k) Clearance

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K954707 · Fujinon, Inc. · Ear, Nose, Throat device
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Nov 1995
Decision
41d
Days
Class 2
Risk

K954707 is an FDA 510(k) clearance for the BRONCHOSCOPE. Classified as Bronchoscope (flexible Or Rigid) (product code EOQ), Class II - Special Controls.

Submitted by Fujinon, Inc. (New York, US). The FDA issued a Cleared decision on November 22, 1995 after a review of 41 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 Fujinon, Inc. devices

Submission Details

510(k) Number K954707 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 1995
Decision Date November 22, 1995
Days to Decision 41 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 89d · This submission: 41d
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 120
Devices cleared under the same product code (EOQ) and FDA review panel - the closest regulatory comparables to K954707.
KARL STORZ INTUBATION FIBERSCOPE
K961178 · KARL STORZ Endoscopy-America, Inc. · May 1996
KARL STORZ HUZLY HIGH-FREQUENCY CUTTING LOOPS
K960791 · KARL STORZ Endoscopy-America, Inc. · Mar 1996
KARL STORZ RHINO-LARYNGO-BRONCHO FIBERSCOPE, FIBERSCOPE FOR BRONCHOSCOPY
K954797 · KARL STORZ Endoscopy-America, Inc. · Jan 1996
SAUER ENDOSCOPE GUIDE AND INTUBATION AID
K954125 · KARL STORZ Endoscopy-America, Inc. · Oct 1995
DISTENDING DIVERTICULOSCOPE
K953596 · KARL STORZ Endoscopy-America, Inc. · Sep 1995
KARL STORZ CATHETERS, ADAPTORS, SUCTION/IRRIGATION CATHETERS, TUBING
K952081 · KARL STORZ Endoscopy-America, Inc. · Jul 1995