Cleared Traditional

TAS-(VARIOUS) ULTRATHIN FLEXIBLE ENDOSCOPE (K942388) - FDA 510(k) Clearance

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

K942388 · Technology Marketing Group · Ear, Nose, Throat device
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Aug 1994
Decision
90d
Days
Class 2
Risk

K942388 is an FDA 510(k) clearance for the TAS-(VARIOUS) ULTRATHIN FLEXIBLE ENDOSCOPE. Classified as Bronchoscope (flexible Or Rigid) (product code EOQ), Class II - Special Controls.

Submitted by Technology Marketing Group (Maywood, US). The FDA issued a Cleared decision on August 17, 1994 after a review of 90 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.

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Submission Details

510(k) Number K942388 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 1994
Decision Date August 17, 1994
Days to Decision 90 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
1d slower than avg
Panel avg: 89d · This submission: 90d
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 K942388.
KARL STORZ STENT APPLICATOR FORCEPS
K950965 · KARL STORZ Endoscopy-America, Inc. · Mar 1995
11274 AB FLEXIBLE PEDIATRIC BRONCHOSCOPE
K931442 · KARL STORZ Endoscopy-America, Inc. · Jan 1995
KARL STORZ BRONCHOSCOPE ACCESSORIES
K943700 · KARL STORZ Endoscopy-America, Inc. · Aug 1994
BRONCHO-FIBERSCOPE
K832010 · KARL STORZ Endoscopy-America, Inc. · Aug 1983