Cleared Traditional

K864160 - LEUKOPLAST POROUS AND SPORT TAPE

K864160 is an FDA 510(k) clearance for LEUKOPLAST POROUS AND SPORT TAPE, manufactured by Beiersdorf, Inc.. The device is a Class 1 General & Plastic Surgery device with product code KGX cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K864160 · Beiersdorf, Inc. · General & Plastic Surgery device
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Nov 1986
Decision
25d
Days
Class 1
Risk

K864160 is an FDA 510(k) clearance for the LEUKOPLAST(R) POROUS AND SPORT TAPE. Classified as Tape And Bandage, Adhesive (product code KGX), Class I - General Controls.

Submitted by Beiersdorf, Inc. (Norwalk, US). The FDA issued a Cleared decision on November 17, 1986 after a review of 25 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 Beiersdorf, Inc. devices

FDA 510(k) Submission Details - K864160

510(k) Number K864160 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1986
Decision Date November 17, 1986
Days to Decision 25 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 115d · This submission: 25d
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 77
Devices cleared under the same product code (KGX) and FDA review panel - the closest regulatory comparables to K864160.
LEUKOPOR(TM) SURGICAL TAPE
K881509 · Beiersdorf, Inc. · Apr 1988
LIGHTPLAST(TM)
K872975 · Beiersdorf, Inc. · Aug 1987
THE GRIPPER SEAL(TM)
K870900 · Pharmacia Deltec, Inc. · Mar 1987
PLASTELAST AND/OR ELASTOPLASTE
K854006 · Cp Medical · Nov 1985
SURGICAL TAPES CLOTH, PAPER & PLASTIC-BASE
K853820 · Abco Dealers, Inc. · Oct 1985
SHEER ADHESIVE BANDAGES, STERILE
K850529 · Abco Dealers, Inc. · May 1985