Cleared Traditional

K150532 - Universal Light Handle Cover, Light Handle Cover

K150532 is an FDA 510(k) clearance for Universal Light Handle Cover, manufactured by Key Surgical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FTA cleared through the Traditional 510(k) pathway after a 204-day FDA review.

K150532 · Key Surgical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2015
Decision
204d
Days
Class 2
Risk

K150532 is an FDA 510(k) clearance for the Universal Light Handle Cover, Light Handle Cover. Classified as Light, Surgical, Accessories (product code FTA), Class II - Special Controls.

Submitted by Key Surgical, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on September 22, 2015 after a review of 204 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Key Surgical, Inc. devices

FDA 510(k) Submission Details - K150532

510(k) Number K150532 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2015
Decision Date September 22, 2015
Days to Decision 204 days
Submission Type Traditional
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
89d slower than avg
Panel avg: 115d · This submission: 204d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FTA Device Classification - Class 2, Special Controls

Product Code FTA Light, Surgical, Accessories
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 - FTA Light, Surgical, Accessories

All 12
Devices cleared under the same product code (FTA) and FDA review panel - the closest regulatory comparables to K150532.
Operating Room Light Handle Adapter
K142386 · Litex Manufacturing, Inc. · Sep 2014
SURGICAL LIGHT HANDLE COVER
K133554 · Microtek Medical, Inc. an Ecolab Company · Apr 2014
IDSS SLC
K133413 · Black Diamond Video · Jan 2014
OASYS SURGICAL LIGHT CONTROLLER
K112133 · Oasys Healthcare · Mar 2012
SCB/STERIS OR-LIGHT INTERFACE BOX
K051505 · KARL STORZ Endoscopy-America, Inc. · Aug 2005
KSEA SCB ACC CONTROL
K023704 · KARL STORZ Endoscopy-America, Inc. · Jan 2003