Cleared Traditional

K930897 - MI-15 EXAM SURGICAL LIGHT

K930897 is an FDA 510(k) clearance for MI-15 EXAM SURGICAL LIGHT, manufactured by Medical Illumination, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FTD cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K930897 · Medical Illumination, Inc. · General & Plastic Surgery device
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Jun 1993
Decision
123d
Days
Class 2
Risk

K930897 is an FDA 510(k) clearance for the MI-15 EXAM SURGICAL LIGHT. Classified as Lamp, Surgical (product code FTD), Class II - Special Controls.

Submitted by Medical Illumination, Inc. (Arleta, US). The FDA issued a Cleared decision on June 25, 1993 after a review of 123 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 Medical Illumination, Inc. devices

FDA 510(k) Submission Details - K930897

510(k) Number K930897 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 1993
Decision Date June 25, 1993
Days to Decision 123 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
8d slower than avg
Panel avg: 115d · This submission: 123d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FTD Device Classification - Class 2, Special Controls

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 17
Devices cleared under the same product code (FTD) and FDA review panel - the closest regulatory comparables to K930897.
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
MINOR SURGICAL LIGHT MODEL 180
K841360 · American Sterilizer Co. · Apr 1984
SURGICAL LIGHT
K823360 · Amsco Co. · Dec 1982
CASTLE & RITTER MINOR SURG. & EXAM LT
K811728 · Sybron Corp. · Jul 1981