Cleared Traditional

K924077 - HANDISOL

K924077 is an FDA 510(k) clearance for HANDISOL, manufactured by National Biological Corp.. The device is a Class 2 General & Plastic Surgery device with product code FTC cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K924077 · National Biological Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1992
Decision
100d
Days
Class 2
Risk

K924077 is an FDA 510(k) clearance for the HANDISOL. Classified as Light, Ultraviolet, Dermatological (product code FTC), Class II - Special Controls.

Submitted by National Biological Corp. (Twinsburg, US). The FDA issued a Cleared decision on November 20, 1992 after a review of 100 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4630 - 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 National Biological Corp. devices

FDA 510(k) Submission Details - K924077

510(k) Number K924077 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1992
Decision Date November 20, 1992
Days to Decision 100 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 115d · This submission: 100d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FTC Device Classification - Class 2, Special Controls

Product Code FTC Light, Ultraviolet, Dermatological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4630
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 - FTC Light, Ultraviolet, Dermatological

All 51
Devices cleared under the same product code (FTC) and FDA review panel - the closest regulatory comparables to K924077.
HANDISOL WOUND HEALING
K982082 · National Biological Corp. · Oct 1998
UVISOL AND UVISOL II
K934808 · National Biological Corp. · Dec 1993
PHOTOTHERAPY TIMER
K924969 · National Biological Corp. · Feb 1993
PANOSOL II UVA-218
K904426 · National Biological Corp. · Dec 1990
PANOSOL II UVB-206
K904427 · National Biological Corp. · Dec 1990
PANOSOL II UAB-228
K904428 · National Biological Corp. · Dec 1990