Cleared Traditional

K944607 - MODEL 5135 AUTO LP/FLASH

K944607 is the FDA 510(k) clearance for MODEL 5135 AUTO LP/FLASH by Richard Wolf Medical Instruments Corp.. It is a Class 2 Gastroenterology & Urology device (product code GCT) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K944607 · Richard Wolf Medical Instruments Corp. · Gastroenterology & Urology device
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Dec 1994
Decision
85d
Days
Class 2
Risk

K944607 is an FDA 510(k) clearance for the MODEL 5135 AUTO LP/FLASH. Classified as Light Source, Endoscope, Xenon Arc (product code GCT), Class II - Special Controls.

Submitted by Richard Wolf Medical Instruments Corp. (Vernon Hills, US). The FDA issued a Cleared decision on December 13, 1994 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology 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 Richard Wolf Medical Instruments Corp. devices

Submission Details

510(k) Number K944607 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1994
Decision Date December 13, 1994
Days to Decision 85 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 130d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GCT Light Source, Endoscope, Xenon Arc
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - GCT Light Source, Endoscope, Xenon Arc

All 18
Devices cleared under the same product code (GCT) and FDA review panel - the closest regulatory comparables to K944607.
ENDOBEAM
K963044 · Corin USA · Sep 1996
XENON NOPPVA
K954561 · KARL STORZ Endoscopy-America, Inc. · Oct 1995
XENON LIGHT SOURCE MODEL 5121
K952696 · Richard Wolf Medical Instruments Corp. · Jul 1995
MODEL 5151
K944821 · Richard Wolf Medical Instruments Corp. · Nov 1994
KARL STORZ XENON LIGHT SOURCE MODEL 201320-20
K934559 · KARL STORZ Endoscopy-America, Inc. · Apr 1994
LCI-100 AND LCI-200 WELCH ALLYN ILLUMINATION AND IMAGING SYSTEM
K940270 · Welch Allyn, Inc. · Apr 1994