Cleared Traditional

K904428 - PANOSOL II UAB-228

K904428 is an FDA 510(k) clearance for PANOSOL II UAB-228, 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 88-day FDA review.

K904428 · National Biological Corp. · General & Plastic Surgery device
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Dec 1990
Decision
88d
Days
Class 2
Risk

K904428 is an FDA 510(k) clearance for the PANOSOL II UAB-228. 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 December 24, 1990 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 878.4630 - 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: 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 National Biological Corp. devices

FDA 510(k) Submission Details - K904428

510(k) Number K904428 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1990
Decision Date December 24, 1990
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.

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 K904428.
HANDISOL
K924077 · National Biological Corp. · Nov 1992
PANOSOL II UVA-218
K904426 · National Biological Corp. · Dec 1990
PANOSOL II UVB-206
K904427 · National Biological Corp. · Dec 1990
HOUVA II UVB
K885026 · National Biological Corp. · Jun 1989
HOUVA II UVA/UVB
K885029 · National Biological Corp. · Jun 1989
HOUVA II UVA
K885025 · National Biological Corp. · Jan 1989