Cleared Traditional

K901154 - MICROTEK'S SURGICAL LAMP HANDLE & COVER

K901154 is an FDA 510(k) clearance for MICROTEK'S SURGICAL LAMP HANDLE & COVER, manufactured by Microbio-Medics, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FTA cleared through the Traditional 510(k) pathway after a 7-day FDA review.

K901154 · Microbio-Medics, Inc. · General & Plastic Surgery device
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Mar 1990
Decision
7d
Days
Class 2
Risk

K901154 is an FDA 510(k) clearance for the MICROTEK'S SURGICAL LAMP HANDLE & COVER. Classified as Light, Surgical, Accessories (product code FTA), Class II - Special Controls.

Submitted by Microbio-Medics, Inc. (Tucker, US). The FDA issued a Cleared decision on March 20, 1990 after a review of 7 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 Microbio-Medics, Inc. devices

FDA 510(k) Submission Details - K901154

510(k) Number K901154 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 1990
Decision Date March 20, 1990
Days to Decision 7 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
108d faster than avg
Panel avg: 115d · This submission: 7d
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

Devices cleared under the same product code (FTA) and FDA review panel - the closest regulatory comparables to K901154.
SCB/STERIS OR-LIGHT INTERFACE BOX
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K810292 · Medline Industries, Inc. · Mar 1981
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K780162 · Cavitron Corp. · Mar 1978