Cleared Traditional

K914076 - MDT/CASTLE 2000 SURGICAL LIGHTS

K914076 is an FDA 510(k) clearance for MDT/CASTLE 2000 SURGICAL LIGHTS, manufactured by Mdt Corp., Inc.. The device is a Class 2 General & Plastic Surgery device with product code FSY cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K914076 · Mdt Corp., Inc. · General & Plastic Surgery device
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Nov 1991
Decision
63d
Days
Class 2
Risk

K914076 is an FDA 510(k) clearance for the MDT/CASTLE 2000 SURGICAL LIGHTS. Classified as Light, Surgical, Ceiling Mounted (product code FSY), Class II - Special Controls.

Submitted by Mdt Corp., Inc. (Rochester, US). The FDA issued a Cleared decision on November 13, 1991 after a review of 63 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 Mdt Corp., Inc. devices

FDA 510(k) Submission Details - K914076

510(k) Number K914076 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1991
Decision Date November 13, 1991
Days to Decision 63 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
52d faster than avg
Panel avg: 115d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FSY Device Classification - Class 2, Special Controls

Product Code FSY Light, Surgical, Ceiling Mounted
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 - FSY Light, Surgical, Ceiling Mounted

All 59
Devices cleared under the same product code (FSY) and FDA review panel - the closest regulatory comparables to K914076.
CHROMOPHARE
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SKYTRON UNIVERSE SERIES SURGICAL LIGHTS
K900211 · Skytron, Div. the Kmw Group, Inc. · Mar 1990
AMSCO QUANTUM LIGHT
K896674 · American Sterilizer Co. · Jan 1990