Cleared Traditional

K900211 - SKYTRON UNIVERSE SERIES SURGICAL LIGHTS

K900211 is an FDA 510(k) clearance for SKYTRON UNIVERSE SERIES SURGICAL LIGHTS, manufactured by Skytron, Div. the Kmw Group, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FSY cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K900211 · Skytron, Div. the Kmw Group, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
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Mar 1990
Decision
61d
Days
Class 2
Risk

K900211 is an FDA 510(k) clearance for the SKYTRON UNIVERSE SERIES SURGICAL LIGHTS. Classified as Light, Surgical, Ceiling Mounted (product code FSY), Class II - Special Controls.

Submitted by Skytron, Div. the Kmw Group, Inc. (Grand Rapids, US). The FDA issued a Cleared decision on March 19, 1990 after a review of 61 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 - K900211

510(k) Number K900211 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 1990
Decision Date March 19, 1990
Days to Decision 61 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
54d faster than avg
Panel avg: 115d · This submission: 61d
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 73
Devices cleared under the same product code (FSY) and FDA review panel - the closest regulatory comparables to K900211.
SHAMPAINE 1000 SERIES ANGENIEUX AX-14 DUO,AX-4
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CHICK III SURGICAL LIGHTING SYSTEM
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AMSCO QUANTUM LIGHT
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KINETIC MODEL 700
K892808 · Kinetic Biomedical Services, Inc. · Jun 1989
KINETIC MODEL 500
K891756 · Kinetic Biomedical Services, Inc. · Apr 1989
K900211 · SKYTRON UNIVERSE SERIES SURGICAL LIGHTS
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