Cleared Abbreviated

K013242 - AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEM

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

K013242 · STERIS Corporation · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
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.

FDA 510(k) Submission Details - K013242

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.

FTD Device Classification - Class 2, Special Controls

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 28
Devices cleared under the same product code (FTD) and FDA review panel - the closest regulatory comparables to K013242.
SCINTILLANT SURGICAL LIGHT, MODEL 2644-01-0001
K071180 · Engineered Medical Solutions Co., LLC · Jun 2007
HALUX IRIS EXAMINATION AND SURGICAL LAMP
K053364 · Waldmann Lighting · Feb 2006
ATRICURE DISSECTOR
K041681 · AtriCure, Inc. · Jul 2004
SOLA 700,SOLA 500, SOLA 300
K010724 · Drager Medizintechnik GmbH · Jun 2001
ST. FRANCIS OPERATING THEATRE LAMP, MODELS OLH01-125 AND LC-055
K003423 · St. Francis Medical Equipment Co., Ltd. · Feb 2001
STRYKER KNIFELIGHT, STRYKER ILLUMINATED RETRACTOR
K981717 · Stryker Instruments · Jun 1998
K013242 · AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEM
Download PDF FDA Summary STERIS Corporation