Cleared Traditional

K896674 - AMSCO QUANTUM LIGHT

K896674 is an FDA 510(k) clearance for AMSCO QUANTUM LIGHT, manufactured by American Sterilizer Co.. The device is a Class 2 General & Plastic Surgery device with product code FSY cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K896674 · American Sterilizer Co. · General & Plastic Surgery device
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Jan 1990
Decision
37d
Days
Class 2
Risk

K896674 is an FDA 510(k) clearance for the AMSCO QUANTUM LIGHT. Classified as Light, Surgical, Ceiling Mounted (product code FSY), Class II - Special Controls.

Submitted by American Sterilizer Co. (Erie, US). The FDA issued a Cleared decision on January 3, 1990 after a review of 37 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 American Sterilizer Co. devices

FDA 510(k) Submission Details - K896674

510(k) Number K896674 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1989
Decision Date January 03, 1990
Days to Decision 37 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
78d faster than avg
Panel avg: 115d · This submission: 37d
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 62
Devices cleared under the same product code (FSY) and FDA review panel - the closest regulatory comparables to K896674.
MDT/CASTLE 2000 SURGICAL LIGHTS
K914076 · Mdt Corp., Inc. · Nov 1991
SURGICAL LIGHTING-CENTRA 450
K902864 · Sds Dental, Inc. · Sep 1990
SKYTRON UNIVERSE SERIES SURGICAL LIGHTS
K900211 · Skytron, Div. the Kmw Group, Inc. · Mar 1990
SMITH & NEPHEW DAYLIGHTER(TM)
K873786 · Smith & Nephew, Inc. · Oct 1987
AMSCO POLARIS SL
K854922 · Amsco Co. · Jan 1986
CASTLE(R) 2510 & 2610 MINOR SURG. LIGHT
K820681 · Sybron Corp. · Apr 1982