Cleared Traditional

K840372 - FLEXIBLE ILLUMINATOR 15

K840372 is an FDA 510(k) clearance for FLEXIBLE ILLUMINATOR 15, manufactured by Suncoast Medical Manufacturers, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FTF cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K840372 · Suncoast Medical Manufacturers, Inc. · General & Plastic Surgery device
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Apr 1984
Decision
88d
Days
Class 2
Risk

K840372 is an FDA 510(k) clearance for the FLEXIBLE ILLUMINATOR 15. Classified as Illuminator, Non-remote (product code FTF), Class II - Special Controls.

Submitted by Suncoast Medical Manufacturers, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 24, 1984 after a review of 88 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 Suncoast Medical Manufacturers, Inc. devices

FDA 510(k) Submission Details - K840372

510(k) Number K840372 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 1984
Decision Date April 24, 1984
Days to Decision 88 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 115d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FTF Device Classification - Class 2, Special Controls

Product Code FTF Illuminator, Non-remote
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.