Cleared Traditional

K942553 - GENESIS

K942553 is the FDA 510(k) clearance for GENESIS by Burton Medical Products Corp.. It is a Class 2 General & Plastic Surgery device (product code FTD) cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K942553 · Burton Medical Products Corp. · General & Plastic Surgery device
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Jun 1994
Decision
23d
Days
Class 2
Risk

K942553 is an FDA 510(k) clearance for the GENESIS. Classified as Lamp, Surgical (product code FTD), Class II - Special Controls.

Submitted by Burton Medical Products Corp. (Chatsworth, US). The FDA issued a Cleared decision on June 23, 1994 after a review of 23 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 Burton Medical Products Corp. devices

Submission Details

510(k) Number K942553 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1994
Decision Date June 23, 1994
Days to Decision 23 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 115d · This submission: 23d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 8
Devices cleared under the same product code (FTD) and FDA review panel - the closest regulatory comparables to K942553.
AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEM
K013242 · STERIS Corporation · Dec 2001
STRYKER KNIFELIGHT, STRYKER ILLUMINATED RETRACTOR
K981717 · Stryker Instruments · Jun 1998
STRYKER KNIFELIGHT
K961122 · Stryker Instruments · Aug 1996
MEDLINE'S EXAMIN, OPERATING ROOM/SURG LIGHTS/LAMPS
K931675 · Medline Industries, Inc. · Feb 1994
PARKE-DAVIS SURGICAL LIGHT
K801353 · Warner-Lambert Co. · Jun 1980