Cleared Traditional

SELOFIX (K821257) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K821257 · Selomas, Inc. · General & Plastic Surgery device
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May 1982
Decision
14d
Days
Class 1
Risk

K821257 is an FDA 510(k) clearance for the SELOFIX. 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 May 14, 1982 after a review of 14 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

Submission Details

510(k) Number K821257 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 1982
Decision Date May 14, 1982
Days to Decision 14 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
101d faster than avg
Panel avg: 115d · This submission: 14d
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 K821257.
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
TEGADERM TRANSPARENT DRESSING
K811291 · 3M Company · Jun 1981