Cleared Traditional

K910942 - AC POWERED AND BATTERY POWERED MEDICAL EXAM. LIGHT

K910942 is an FDA 510(k) clearance for AC POWERED AND BATTERY POWERED MEDICAL ..., manufactured by Mdt Biologic Co.. The device is a Class 2 General & Plastic Surgery device with product code FSS cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K910942 · Mdt Biologic Co. · General & Plastic Surgery device
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Jun 1991
Decision
97d
Days
Class 2
Risk

K910942 is an FDA 510(k) clearance for the AC POWERED AND BATTERY POWERED MEDICAL EXAM. LIGHT. Classified as Light, Surgical, Floor Standing (product code FSS), Class II - Special Controls.

Submitted by Mdt Biologic Co. (Rochester, US). The FDA issued a Cleared decision on June 11, 1991 after a review of 97 days - within the typical 510(k) review window.

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 Mdt Biologic Co. devices

FDA 510(k) Submission Details - K910942

510(k) Number K910942 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 1991
Decision Date June 11, 1991
Days to Decision 97 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 115d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FSS Device Classification - Class 2, Special Controls

Product Code FSS Light, Surgical, Floor Standing
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 - FSS Light, Surgical, Floor Standing

All 10
Devices cleared under the same product code (FSS) and FDA review panel - the closest regulatory comparables to K910942.
HANAULUX BLUE 80 HOSPITAL
K970886 · Heraeus Med GmbH · Apr 1997
Q-5000
K961971 · Stryker Endoscopy · Jun 1996
LIGHTSOURCE OR ILLUMINATOR
K961074 · Cuda Products Co. · Apr 1996
LIGHT, SURGICAL, FLOOR STANDING
K880540 · Ferguson Medical · Feb 1988
GEMINI SURGICAL LIGHT
K880198 · American Sterilizer Co. · Feb 1988