Cleared Traditional

SANAPLAST (K881397) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K881397 · Nebo Industries · General & Plastic Surgery device
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Jun 1988
Decision
71d
Days
Class 1
Risk

K881397 is an FDA 510(k) clearance for the SANAPLAST. Classified as Tape And Bandage, Adhesive (product code KGX), Class I - General Controls.

Submitted by Nebo Industries (Fountain Green, US). The FDA issued a Cleared decision on June 14, 1988 after a review of 71 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 Nebo Industries devices

Submission Details

510(k) Number K881397 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1988
Decision Date June 14, 1988
Days to Decision 71 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
44d faster than avg
Panel avg: 115d · This submission: 71d
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 K881397.
TEGADERM BRAND TRANSPARENT DRESSING SERIES 16XX
K901845 · 3M Company · Jul 1990
MODIFIED SUTURE USED IN CATHETER INSERTION TRAYS
K892450 · Quinton, Inc. · Oct 1989
DERMASTRIP
K883660 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1989
SURGICAL TAPES CLOTH, PAPER & PLASTIC-BASE
K853820 · Abco Dealers, Inc. · Oct 1985
SHEER ADHESIVE BANDAGES, STERILE
K850529 · Abco Dealers, Inc. · May 1985
BAND-AID BRAND ADHESIVE BANDAGE-MEDICA
K842511 · Johnson & Johnson Professionals, Inc. · Nov 1984