Cleared Traditional

K952691 - WELCH ALLYN PREMIUM LIGHTWEIGHT HEADLIGHT

K952691 is the FDA 510(k) clearance for WELCH ALLYN PREMIUM LIGHTWEIGHT HEADLIGHT by Welch Allyn, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FJC) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K952691 · Welch Allyn, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1995
Decision
49d
Days
Class 2
Risk

K952691 is an FDA 510(k) clearance for the WELCH ALLYN PREMIUM LIGHTWEIGHT HEADLIGHT. Classified as Detector, Blood Level (product code FJC), Class II - Special Controls.

Submitted by Welch Allyn, Inc. (Skaneateles Falls, US). The FDA issued a Cleared decision on July 31, 1995 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5820 - 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 K952691 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1995
Decision Date July 31, 1995
Days to Decision 49 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
81d faster than avg
Panel avg: 130d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FJC Detector, Blood Level
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5820
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.