Cleared Traditional

K791886 - I.V. CARE KIT

K791886 is the FDA 510(k) clearance for I.V. CARE KIT by Ascep, Inc.. It is a Class 1 General & Plastic Surgery device (product code KGX) cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K791886 · Ascep, Inc. · General & Plastic Surgery device
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Oct 1979
Decision
45d
Days
Class 1
Risk

K791886 is an FDA 510(k) clearance for the I.V. CARE KIT. Classified as Tape And Bandage, Adhesive (product code KGX), Class I - General Controls.

Submitted by Ascep, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 26, 1979 after a review of 45 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 Ascep, Inc. devices

Submission Details

510(k) Number K791886 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1979
Decision Date October 26, 1979
Days to Decision 45 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
70d faster than avg
Panel avg: 115d · This submission: 45d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 74
Devices cleared under the same product code (KGX) and FDA review panel - the closest regulatory comparables to K791886.
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