Cleared Traditional

K053321 - LIGHT GUARD LIGHT HANDLE AND LIGHT HANDLE COVER

K053321 is an FDA 510(k) clearance for LIGHT GUARD LIGHT HANDLE AND LIGHT HAND..., manufactured by Xodus Medical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FTA cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K053321 · Xodus Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2006
Decision
50d
Days
Class 2
Risk

K053321 is an FDA 510(k) clearance for the LIGHT GUARD LIGHT HANDLE AND LIGHT HANDLE COVER. Classified as Light, Surgical, Accessories (product code FTA), Class II - Special Controls.

Submitted by Xodus Medical, Inc. (New Kensington, US). The FDA issued a Cleared decision on January 19, 2006 after a review of 50 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 Xodus Medical, Inc. devices

FDA 510(k) Submission Details - K053321

510(k) Number K053321 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 2005
Decision Date January 19, 2006
Days to Decision 50 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
65d faster than avg
Panel avg: 115d · This submission: 50d
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 13
Devices cleared under the same product code (FTA) and FDA review panel - the closest regulatory comparables to K053321.
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
KSEA SCB MEDIA CONTROL
K020640 · KARL STORZ Endoscopy-America, Inc. · May 2002