Cleared Traditional

K980281 - WELCH ALLYN XENON 300 LIGHT SOURCE

K980281 is an FDA 510(k) clearance for WELCH ALLYN XENON 300 LIGHT SOURCE, manufactured by Welch Allyn, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code GCT cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K980281 · Welch Allyn, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1998
Decision
32d
Days
Class 2
Risk

K980281 is an FDA 510(k) clearance for the WELCH ALLYN XENON 300 LIGHT SOURCE. Classified as Light Source, Endoscope, Xenon Arc (product code GCT), Class II - Special Controls.

Submitted by Welch Allyn, Inc. (Skaneateles Falls, US). The FDA issued a Cleared decision on February 27, 1998 after a review of 32 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 - K980281

510(k) Number K980281 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 1998
Decision Date February 27, 1998
Days to Decision 32 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
99d faster than avg
Panel avg: 131d · This submission: 32d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GCT Device Classification - Class 2, Special Controls

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 28
Devices cleared under the same product code (GCT) and FDA review panel - the closest regulatory comparables to K980281.
XENON LIGHT SOURCE AUTO LIP 5123, MODEL 2123.011
K983628 · Richard Wolf Medical Instruments Corp. · Dec 1998
XENON LIGHT SOURCE, MODELS LS6180, LS6035
K982962 · Contec Medical Vision, Ltd. · Sep 1998
XENON LIGHT SOURCE MODEL LS6000
K981804 · Contec Medical Vision, Ltd. · Jul 1998
COGENLIGHT TECHNOLOGIES XLS ILLUMINATOR SYSTEM
K971057 · Cogent Light Technologies, Inc. · Mar 1997
WHITE SUN LIGHT SOURCE MODEL #: XL300 AND #: XL175
K963227 · Products For Medicine · Oct 1996
ENDOBEAM
K963044 · Corin USA · Sep 1996