Cleared Traditional

K842609 - R.L. MEDICAL TWIN LIGHT SOURCE

K842609 is the FDA 510(k) clearance for R.L. MEDICAL TWIN LIGHT SOURCE by Tridak Division of Indicon, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FCW) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K842609 · Tridak Division of Indicon, Inc. · Gastroenterology & Urology device
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Aug 1984
Decision
35d
Days
Class 2
Risk

K842609 is an FDA 510(k) clearance for the R.L. MEDICAL TWIN LIGHT SOURCE. Classified as Light Source, Fiberoptic, Routine (product code FCW), Class II - Special Controls.

Submitted by Tridak Division of Indicon, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 9, 1984 after a review of 35 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 Tridak Division of Indicon, Inc. devices

Submission Details

510(k) Number K842609 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 1984
Decision Date August 09, 1984
Days to Decision 35 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
95d faster than avg
Panel avg: 130d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 13
Devices cleared under the same product code (FCW) and FDA review panel - the closest regulatory comparables to K842609.
AUTO SUTURE DISPOSABLE LIGHT CABLE
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STORZ S6000 LIGHT SOURCE
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WELCH ALLYN FIBER OPTIC CABLES VARIOUS MODELS
K852951 · Welch Allyn, Inc. · Aug 1985
PEDIATRIC ILLUMINATING URETERAL
K832807 · Van-Tec, Inc. · Oct 1983
PENTAX LH-150F LIGHT SOURCE
K771739 · Pilling Co. · Sep 1977
ADAPTER, FIBER OPTICS HEADLIGHT
K760647 · Pilling Co. · Dec 1976