Cleared Abbreviated

K013242 - AMSCO HARMONY SURGICAL LIGHTING AND MED...

K013242 is the FDA 510(k) clearance for AMSCO HARMONY SURGICAL LIGHTING AND MED... by STERIS Corporation. It is a Class 2 General & Plastic Surgery device (product code FTD) cleared through the Abbreviated 510(k) pathway after a 76-day FDA review.

K013242 · STERIS Corporation · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Dec 2001
Decision
76d
Days
Class 2
Risk

K013242 is an FDA 510(k) clearance for the AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEM. Classified as Lamp, Surgical (product code FTD), Class II - Special Controls.

Submitted by STERIS Corporation (Montgomery, US). The FDA issued a Cleared decision on December 13, 2001 after a review of 76 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all STERIS Corporation devices

Submission Details

510(k) Number K013242 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2001
Decision Date December 13, 2001
Days to Decision 76 days
Submission Type Abbreviated
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 115d · This submission: 76d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code FTD Lamp, Surgical
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 - FTD Lamp, Surgical

All 9
Devices cleared under the same product code (FTD) and FDA review panel - the closest regulatory comparables to K013242.
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