Cleared Traditional

K854020 - G-T 1000

K854020 is an FDA 510(k) clearance for G-T 1000, manufactured by G-T Products. The device is a Class 2 General & Plastic Surgery device with product code FTC cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K854020 · G-T Products · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1985
Decision
46d
Days
Class 2
Risk

K854020 is an FDA 510(k) clearance for the G-T 1000. Classified as Light, Ultraviolet, Dermatological (product code FTC), Class II - Special Controls.

Submitted by G-T Products (Haleyville, US). The FDA issued a Cleared decision on November 15, 1985 after a review of 46 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 G-T Products devices

FDA 510(k) Submission Details - K854020

510(k) Number K854020 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1985
Decision Date November 15, 1985
Days to Decision 46 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 115d · This submission: 46d
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 86
Devices cleared under the same product code (FTC) and FDA review panel - the closest regulatory comparables to K854020.
HAND/FOOT 624-208
K872604 · National Biological Corp. · Jul 1987
HAND/FOOT UVA 624-218
K872605 · National Biological Corp. · Jul 1987
MAXI-TAN DEVICE
K864546 · National Biological Corp. · Jan 1987
FOLDALITE UNIT
K827890 · National Biological Corp. · Aug 1982
HOUVA-LITE ARM UNIT #601
K761186 · National Biological Corp. · Feb 1977
HOUVA-LITE LEG UNIT #701
K761187 · National Biological Corp. · Feb 1977