Cleared Traditional

K860071 - HOLD-IT FRAMED ADHESIVE FILM

K860071 is an FDA 510(k) clearance for HOLD-IT FRAMED ADHESIVE FILM, manufactured by Vlv Associates, Inc.. The device is a Class 1 General Hospital device with product code KMK cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K860071 · Vlv Associates, Inc. · General Hospital
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Jan 1986
Decision
21d
Days
Class 1
Risk

K860071 is an FDA 510(k) clearance for the HOLD-IT FRAMED ADHESIVE FILM. Classified as Device, Intravascular Catheter Securement (product code KMK), Class I - General Controls.

Submitted by Vlv Associates, Inc. (East Hanover, US). The FDA issued a Cleared decision on January 27, 1986 after a review of 21 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5210 - the FDA general hospital 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 Vlv Associates, Inc. devices

FDA 510(k) Submission Details - K860071

510(k) Number K860071 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1986
Decision Date January 27, 1986
Days to Decision 21 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
108d faster than avg
Panel avg: 129d · This submission: 21d
Pathway characteristics
Predicate-based equivalence.

KMK Device Classification - Class 1, General Controls

Product Code KMK Device, Intravascular Catheter Securement
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5210
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 - KMK Device, Intravascular Catheter Securement

All 12
Devices cleared under the same product code (KMK) and FDA review panel - the closest regulatory comparables to K860071.
IAB ANCHOR
K922103 · Datascope Corp. · Aug 1993
DESERET POSITIONAL SUTURE WING
K915495 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1992
TIMLEINE(TM) VENIPUNCTURE SYSTEM
K870770 · Ipax, Inc. · Apr 1987
SAFTI-BRACELET
K853418 · Advanced Biosearch Assn. · Sep 1985
ACU-DERM TRANSPARENT IV DRESSING
K842064 · Acme United Corp. · Aug 1984
AEGIS I.V. STRIPS
K812080 · Warner-Lambert Co. · Aug 1981