Cleared Traditional

K780719 - FUNGUS FIGHTER INSOLES

K780719 is an FDA 510(k) clearance for FUNGUS FIGHTER INSOLES, manufactured by Combe, Inc.. The device is a Class 1 General Hospital device with product code KYS cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K780719 · Combe, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1978
Decision
162d
Days
Class 1
Risk

K780719 is an FDA 510(k) clearance for the FUNGUS FIGHTER INSOLES. Classified as Insoles, Medical (product code KYS), Class I - General Controls.

Submitted by Combe, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 10, 1978 after a review of 162 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6280 - the FDA general hospital 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 Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Combe, Inc. devices

FDA 510(k) Submission Details - K780719

510(k) Number K780719 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1978
Decision Date October 10, 1978
Days to Decision 162 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 129d · This submission: 162d
Pathway characteristics
Predicate-based equivalence.

KYS Device Classification - Class 1, General Controls

Product Code KYS Insoles, Medical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6280
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.