Cleared Traditional

K992090 - MILLENNIUM GOLD

K992090 is an FDA 510(k) clearance for MILLENNIUM GOLD, 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 79-day FDA review.

K992090 · Skytron, Div. the Kmw Group, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1999
Decision
79d
Days
Class 2
Risk

K992090 is an FDA 510(k) clearance for the MILLENNIUM GOLD. 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 September 8, 1999 after a review of 79 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 - K992090

510(k) Number K992090 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 1999
Decision Date September 08, 1999
Days to Decision 79 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
36d faster than avg
Panel avg: 115d · This submission: 79d
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 K992090.
STELLAR
K002463 · Skytron, Div. the Kmw Group, Inc. · Nov 2000
VISIONARY 2000
K000639 · Burton Medical Products Corp. · May 2000
CASTLE SURGICAL LIGHT, MODEL 3000
K993242 · Getinge/Castle, Inc. · Nov 1999
CHROMOPHARE D 530 LDR SURGICAL LIGHT
K990656 · Berchtold Holding GmbH · Jul 1999
CHROMOPHARE D500, D530, D650
K991527 · Berchtold Holding GmbH · May 1999
DRAGER SOLA SERIES, MODELS 1000/700/500/300
K984611 · Drager Medizintechnik GmbH · Mar 1999
K992090 · MILLENNIUM GOLD
Download PDF Skytron, Div. the Kmw…