Cleared Traditional

K901491 - CUDA SURGICAL LIGHT

K901491 is an FDA 510(k) clearance for CUDA SURGICAL LIGHT, manufactured by Cuda Products Co.. The device is a Class 2 General & Plastic Surgery device with product code FST cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K901491 · Cuda Products Co. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1990
Decision
81d
Days
Class 2
Risk

K901491 is an FDA 510(k) clearance for the CUDA SURGICAL LIGHT. Classified as Light, Surgical, Fiberoptic (product code FST), Class II - Special Controls.

Submitted by Cuda Products Co. (Jacksonville, US). The FDA issued a Cleared decision on June 18, 1990 after a review of 81 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

FDA 510(k) Submission Details - K901491

510(k) Number K901491 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1990
Decision Date June 18, 1990
Days to Decision 81 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 115d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FST Device Classification - Class 2, Special Controls

Product Code FST Light, Surgical, Fiberoptic
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 - FST Light, Surgical, Fiberoptic

All 27
Devices cleared under the same product code (FST) and FDA review panel - the closest regulatory comparables to K901491.
X6000D SILENT SUN LIGHT SOURCE
K955510 · Products For Medicine · Jan 1996
MEDICAM 900 AUTOELECTRONIC LIGHT SOURCE
K922544 · Kirschner Medical Corp. · Aug 1992
METAL HALIDE LIGHT SOURCE MODEL LM 250
K915274 · Pentax Precision Instrument Corp. · Jan 1992
FIBER OPTIC LIGHT GUIDE OR FIBER OPTIC CABLE
K901035 · Cuda Products Co. · Apr 1990
MODEL M2-150/I-150/M2-150T/M3-150/M2-150,300-300
K893491 · Cuda Products Co. · Jun 1989
PRISMA DISPOS. BRITE LITE FIBEROPTIC ENDO. W/PICK
K875004 · Advanced Surgical Products, Inc. · Mar 1988