Cleared Traditional

K981962 - CUDA PRODUCTS CORP. MODEL M300 (M-300) ...

K981962 is the FDA 510(k) clearance for CUDA PRODUCTS CORP. MODEL M300 (M-300) ... by Cuda Products Co.. It is a Class 2 General & Plastic Surgery device (product code FSS) cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K981962 · Cuda Products Co. · General & Plastic Surgery device
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Aug 1998
Decision
75d
Days
Class 2
Risk

K981962 is an FDA 510(k) clearance for the CUDA PRODUCTS CORP. MODEL M300 (M-300) LIGHTSOURCE. 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 August 18, 1998 after a review of 75 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.

View all Cuda Products Co. devices

Submission Details

510(k) Number K981962 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1998
Decision Date August 18, 1998
Days to Decision 75 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 115d · This submission: 75d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.