Cleared Traditional

K142076 - CLAVEGUARD FREEDOM SURGICAL LIGHT

K142076 is an FDA 510(k) clearance for CLAVEGUARD FREEDOM SURGICAL LIGHT, manufactured by Dickson & Dickson Healthcare (Us), Inc.. The device is a Class 2 General & Plastic Surgery device with product code FSY cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K142076 · Dickson & Dickson Healthcare (Us), Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2014
Decision
61d
Days
Class 2
Risk

K142076 is an FDA 510(k) clearance for the CLAVEGUARD FREEDOM SURGICAL LIGHT. Classified as Light, Surgical, Ceiling Mounted (product code FSY), Class II - Special Controls.

Submitted by Dickson & Dickson Healthcare (Us), Inc. (Richmond, US). The FDA issued a Cleared decision on September 30, 2014 after a review of 61 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 Dickson & Dickson Healthcare (Us), Inc. devices

FDA 510(k) Submission Details - K142076

510(k) Number K142076 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2014
Decision Date September 30, 2014
Days to Decision 61 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
54d faster than avg
Panel avg: 115d · This submission: 61d
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 7
Devices cleared under the same product code (FSY) and FDA review panel - the closest regulatory comparables to K142076.
HARMONY LED-1 SURGICAL LIGHTING SYSTEM
K072072 · STERIS Corporation · Oct 2007
STRYKER VISUM SURGICAL LIGHTING SYSTEM
K031068 · Stryker Endoscopy · Aug 2003
BRIGHTSTAR
K981081 · Hill-Rom, Inc. · Apr 1998
AMSCO SQ240 SURGICAL LIGHT
K943288 · American Sterilizer Co. · Oct 1994
AMSCO QUANTUM LIGHT
K896674 · American Sterilizer Co. · Jan 1990
SMITH & NEPHEW DAYLIGHTER(TM)
K873786 · Smith & Nephew, Inc. · Oct 1987