Cleared Traditional

FLEX SIGMOIDOSCOPE LIGHT SOURCE MODEL #45150 (K893440) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K893440 · Welch Allyn, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1989
Decision
86d
Days
Class 2
Risk

K893440 is an FDA 510(k) clearance for the FLEX SIGMOIDOSCOPE LIGHT SOURCE MODEL #45150. Classified as Image, Illumination, Fiberoptic, For Endoscope (product code FFS), Class II - Special Controls.

Submitted by Welch Allyn, Inc. (Skaneateles Falls, US). The FDA issued a Cleared decision on July 28, 1989 after a review of 86 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

Submission Details

510(k) Number K893440 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 1989
Decision Date July 28, 1989
Days to Decision 86 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 130d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FFS Image, Illumination, Fiberoptic, For Endoscope
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 - FFS Image, Illumination, Fiberoptic, For Endoscope

All 25
Devices cleared under the same product code (FFS) and FDA review panel - the closest regulatory comparables to K893440.
SMITH & NEPHEW XENON LIGHT SOURCES AND ACCESSORIES
K994084 · Smith & Nephew, Inc. · Jan 2000
SMITH & NEPHEW SUBCUTANEOUS ILLUMINATOR
K991323 · Smith & Nephew, Inc. · Jul 1999
KARL STORZ XENON 300 LIGHT SOURCE FOR NON-FLASH APPLICATIONS
K962595 · KARL STORZ Endoscopy-America, Inc. · Sep 1996
KARL STORZ ENDOSCOPY-AMERICA, INC.
K933216 · KARL STORZ Endoscopy-America, Inc. · Sep 1993