Cleared Traditional

K821490 - SILKAFIX ADHESIVE PLASTER

K821490 is an FDA 510(k) clearance for SILKAFIX ADHESIVE PLASTER, manufactured by Selomas, Inc.. The device is a Class 1 General & Plastic Surgery device with product code KGX cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K821490 · Selomas, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1982
Decision
15d
Days
Class 1
Risk

K821490 is an FDA 510(k) clearance for the SILKAFIX ADHESIVE PLASTER. Classified as Tape And Bandage, Adhesive (product code KGX), Class I - General Controls.

Submitted by Selomas, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 2, 1982 after a review of 15 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 Selomas, Inc. devices

FDA 510(k) Submission Details - K821490

510(k) Number K821490 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1982
Decision Date June 02, 1982
Days to Decision 15 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
100d faster than avg
Panel avg: 115d · This submission: 15d
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 K821490.
BREATHABLE OVERWRAY BANDAGE NON-ELAS
K833731 · American Medical Disposable, Inc. · Jan 1984
ONE TIME COMPOUND BENZOIN TINCTURE-
K833120 · Acme United Corp. · Dec 1983
3M STERI-STRIP ANTIMICROBIAL SKIN CLOS
K813265 · 3M Company · Feb 1983
CURITY SHETHOSCOPE SECURING PADS
K820872 · The Kendal Co. · Apr 1982
NON-ADHER PADS
K813421 · Abco Dealers, Inc. · Dec 1981
ETHICON* SKIN CLOSURE TAPE
K813124 · Ethicon, Inc. · Dec 1981