Cleared Traditional

K854922 - AMSCO POLARIS SL

K854922 is an FDA 510(k) clearance for AMSCO POLARIS SL, manufactured by Amsco Co.. The device is a Class 2 General & Plastic Surgery device with product code FSY cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K854922 · Amsco Co. · General & Plastic Surgery device
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Jan 1986
Decision
45d
Days
Class 2
Risk

K854922 is an FDA 510(k) clearance for the AMSCO POLARIS SL. Classified as Light, Surgical, Ceiling Mounted (product code FSY), Class II - Special Controls.

Submitted by Amsco Co. (Erie, US). The FDA issued a Cleared decision on January 24, 1986 after a review of 45 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 Amsco Co. devices

FDA 510(k) Submission Details - K854922

510(k) Number K854922 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 1985
Decision Date January 24, 1986
Days to Decision 45 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
70d faster than avg
Panel avg: 115d · This submission: 45d
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 52
Devices cleared under the same product code (FSY) and FDA review panel - the closest regulatory comparables to K854922.
SKYTRON UNIVERSE SERIES SURGICAL LIGHTS
K900211 · Skytron, Div. the Kmw Group, Inc. · Mar 1990
AMSCO QUANTUM LIGHT
K896674 · American Sterilizer Co. · Jan 1990
SMITH & NEPHEW DAYLIGHTER(TM)
K873786 · Smith & Nephew, Inc. · Oct 1987
CASTLE(R) 2510 & 2610 MINOR SURG. LIGHT
K820681 · Sybron Corp. · Apr 1982
9100 DAYSTAR AND 9110 ORBITER PACKAGE
K781887 · Castle Co. · Dec 1978
DAYSTAR SELECTRA & SELECTRA/ORBITER
K780666 · Castle Co. · Apr 1978