Cleared Traditional

SYSTENET (K832544) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K832544 · American Intl. Medical Supply Co. · General & Plastic Surgery device
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Nov 1983
Decision
123d
Days
Class 1
Risk

K832544 is an FDA 510(k) clearance for the SYSTENET. Classified as Tape And Bandage, Adhesive (product code KGX), Class I - General Controls.

Submitted by American Intl. Medical Supply Co. (Walker, US). The FDA issued a Cleared decision on November 29, 1983 after a review of 123 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all American Intl. Medical Supply Co. devices

Submission Details

510(k) Number K832544 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1983
Decision Date November 29, 1983
Days to Decision 123 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
8d slower than avg
Panel avg: 115d · This submission: 123d
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 24
Devices cleared under the same product code (KGX) and FDA review panel - the closest regulatory comparables to K832544.
BAND-AID BRAND ADHESIVE BANDAGE-MEDICA
K842511 · Johnson & Johnson Professionals, Inc. · Nov 1984
MELOLITE
K833954 · Smith & Nephew, Inc. · Mar 1984
HYPAFIX DRESSING RETENTION SHEET
K833916 · Smith & Nephew, Inc. · Mar 1984
3M STERI-STRIP ANTIMICROBIAL SKIN CLOS
K813265 · 3M Company · Feb 1983
NON-ADHER PADS
K813421 · Abco Dealers, Inc. · Dec 1981
ETHICON* SKIN CLOSURE TAPE
K813124 · Ethicon, Inc. · Dec 1981