Cleared Traditional

I.V. START SET (K791885) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K791885 · Ascep, Inc. · General & Plastic Surgery device
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Oct 1979
Decision
41d
Days
Class 1
Risk

K791885 is an FDA 510(k) clearance for the I.V. START SET. 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 22, 1979 after a review of 41 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 K791885 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1979
Decision Date October 22, 1979
Days to Decision 41 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
74d faster than avg
Panel avg: 115d · This submission: 41d
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 19
Devices cleared under the same product code (KGX) and FDA review panel - the closest regulatory comparables to K791885.
JOHNSON & JOHNSON ADHESIVE FILM DRESSING
K810053 · Johnson & Johnson Professionals, Inc. · Jan 1981
3M HI-STRENGTH MED. TAPE #1534
K802242 · 3M Company · Sep 1980
ELASTIC ADHESIVE BANDAGES(STERILE)
K801794 · Smith & Nephew, Inc. · Aug 1980
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