Cleared Traditional

K142386 - Operating Room Light Handle Adapter

K142386 is an FDA 510(k) clearance for Operating Room Light Handle Adapter, manufactured by Litex Manufacturing, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FTA cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K142386 · Litex Manufacturing, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2014
Decision
33d
Days
Class 2
Risk

K142386 is an FDA 510(k) clearance for the Operating Room Light Handle Adapter. Classified as Light, Surgical, Accessories (product code FTA), Class II - Special Controls.

Submitted by Litex Manufacturing, Inc. (Glendale, US). The FDA issued a Cleared decision on September 29, 2014 after a review of 33 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.

FDA 510(k) Submission Details - K142386

510(k) Number K142386 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 2014
Decision Date September 29, 2014
Days to Decision 33 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 115d · This submission: 33d
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 25
Devices cleared under the same product code (FTA) and FDA review panel - the closest regulatory comparables to K142386.
Universal Light Handle Cover, Light Handle Cover
K150532 · Key Surgical, Inc. · Sep 2015
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
EASYSUITE SURGICAL LIGHT CONTROL (ESLC)
K102791 · Image Stream Medical, Inc. · Nov 2010
MAINSTREAM OR SURGICAL LIGHT CONTROL (MSLC)
K081698 · Image Stream Medical, Inc. · Jul 2008
K142386 · Operating Room Light Handle Adapter
Download PDF FDA Summary Litex Manufacturing, …