Cleared Traditional

K951647 - WELCH ALLYN HI - LUX ILLUMINATOR

K951647 is an FDA 510(k) clearance for WELCH ALLYN HI - LUX ILLUMINATOR, manufactured by Welch Allyn, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FCW cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K951647 · Welch Allyn, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1995
Decision
37d
Days
Class 2
Risk

K951647 is an FDA 510(k) clearance for the WELCH ALLYN HI - LUX ILLUMINATOR. Classified as Light Source, Fiberoptic, Routine (product code FCW), Class II - Special Controls.

Submitted by Welch Allyn, Inc. (Skaneateles Falls, US). The FDA issued a Cleared decision on May 17, 1995 after a review of 37 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 Welch Allyn, Inc. devices

FDA 510(k) Submission Details - K951647

510(k) Number K951647 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1995
Decision Date May 17, 1995
Days to Decision 37 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 131d · This submission: 37d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FCW Device Classification - Class 2, Special Controls

Product Code FCW Light Source, Fiberoptic, Routine
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 - FCW Light Source, Fiberoptic, Routine

All 20
Devices cleared under the same product code (FCW) and FDA review panel - the closest regulatory comparables to K951647.
INTEGRATED VISUALIZATION SYSTEM
K970598 · Urohealth, Inc. · Mar 1997
PRESCOTT'S LIGHT SOURCE MODEL NO. II-150
K964586 · Iba/Griffith · Jan 1997
ENDOSPOT
K963043 · Corin USA · Sep 1996
CHAKOFF ENDOSCOPY
K945420 · Stephen Chakoff, Inc. · Dec 1994
AUTO SUTURE DISPOSABLE LIGHT CABLE
K934531 · United States Surgical, A Division of Tyco Healthc · May 1994
CUDA PRODUCTS CORP. LIGHTSOURCES
K933369 · Cuda Products Co. · Jan 1994