Cleared Traditional

K791288 - YELLOW ALERT SYSTEM

K791288 is an FDA 510(k) clearance for YELLOW ALERT SYSTEM, manufactured by Hemoy, Inc.. The device is a Class 1 General & Plastic Surgery device with product code KGX cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K791288 · Hemoy, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1979
Decision
24d
Days
Class 1
Risk

K791288 is an FDA 510(k) clearance for the YELLOW ALERT SYSTEM. Classified as Tape And Bandage, Adhesive (product code KGX), Class I - General Controls.

Submitted by Hemoy, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 3, 1979 after a review of 24 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.5240 - 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 Hemoy, Inc. devices

FDA 510(k) Submission Details - K791288

510(k) Number K791288 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 1979
Decision Date August 03, 1979
Days to Decision 24 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
91d faster than avg
Panel avg: 115d · This submission: 24d
Pathway characteristics
Predicate-based equivalence.

KGX Device Classification - Class 1, General Controls

Product Code KGX Tape And Bandage, Adhesive
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5240
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.

Regulatory Peers - KGX Tape And Bandage, Adhesive

All 91
Devices cleared under the same product code (KGX) and FDA review panel - the closest regulatory comparables to K791288.
LEUKOPOR
K792666 · Beiersdorf, Inc. · Jan 1980
HYPO-ALLERGENIC CLOTH ADHESIVE TAPE
K792102 · National Patent Development Corp. · Nov 1979
HYPO-ALLERGENIC PAPER ADHESIVE TAPE
K792103 · National Patent Development Corp. · Nov 1979
TAPE, DERMICEL, CLOTH
K770362 · Johnson & Johnson Professionals, Inc. · Jun 1977
BAND-AID BRAND SHEER BANDAGES
K761335 · Johnson & Johnson Professionals, Inc. · Jan 1977
BAND-AID BRAND PLASTIC BANDAGES
K761336 · Johnson & Johnson Professionals, Inc. · Jan 1977