Cleared Traditional

K853646 - NITTO SURGICAL NON-WOVEN TAPE ST-320

K853646 is an FDA 510(k) clearance for NITTO SURGICAL NON-WOVEN TAPE ST-320, manufactured by Nitto Denko America, Inc.. The device is a Class 1 General & Plastic Surgery device with product code KGX cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K853646 · Nitto Denko America, Inc. · General & Plastic Surgery device
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Sep 1985
Decision
16d
Days
Class 1
Risk

K853646 is an FDA 510(k) clearance for the NITTO SURGICAL NON-WOVEN TAPE ST-320. Classified as Tape And Bandage, Adhesive (product code KGX), Class I - General Controls.

Submitted by Nitto Denko America, Inc. (Santa Clara, US). The FDA issued a Cleared decision on September 19, 1985 after a review of 16 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 Nitto Denko America, Inc. devices

FDA 510(k) Submission Details - K853646

510(k) Number K853646 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1985
Decision Date September 19, 1985
Days to Decision 16 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
99d faster than avg
Panel avg: 115d · This submission: 16d
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 K853646.
LEUKOPLAST(R) POROUS AND SPORT TAPE
K864160 · Beiersdorf, Inc. · Nov 1986
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
LEUKOFIX R
K843873 · Beiersdorf, Inc. · Feb 1985
LEUKOPOR SURGICAL TAPE
K843874 · Beiersdorf, Inc. · Feb 1985