Cleared Traditional

K961074 - LIGHTSOURCE OR ILLUMINATOR

K961074 is an FDA 510(k) clearance for LIGHTSOURCE OR ILLUMINATOR, manufactured by Cuda Products Co.. The device is a Class 2 General & Plastic Surgery device with product code FSS cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K961074 · Cuda Products Co. · General & Plastic Surgery device
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Apr 1996
Decision
43d
Days
Class 2
Risk

K961074 is an FDA 510(k) clearance for the LIGHTSOURCE OR ILLUMINATOR. Classified as Light, Surgical, Floor Standing (product code FSS), Class II - Special Controls.

Submitted by Cuda Products Co. (Jacksonville, US). The FDA issued a Cleared decision on April 30, 1996 after a review of 43 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4580 - the FDA general and plastic surgery 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.

FDA 510(k) Submission Details - K961074

510(k) Number K961074 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1996
Decision Date April 30, 1996
Days to Decision 43 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 115d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FSS Device Classification - Class 2, Special Controls

Product Code FSS Light, Surgical, Floor Standing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4580
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - FSS Light, Surgical, Floor Standing

All 19
Devices cleared under the same product code (FSS) and FDA review panel - the closest regulatory comparables to K961074.
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TRI*STAR
K930711 · Light Technology Systems · Jul 1993
AC POWERED AND BATTERY POWERED MEDICAL EXAM. LIGHT
K910942 · Mdt Biologic Co. · Jun 1991
MODEL FEL5100 FLOOR LIGHT
K895950 · F.W. Lang Co. · Oct 1989
K961074 · LIGHTSOURCE OR ILLUMINATOR
Download PDF Cuda Products Co.