Cleared Traditional

K831611 - UNI-THANE

K831611 is an FDA 510(k) clearance for UNI-THANE, manufactured by Carapac Systems, Inc.. The device is a Class 1 General & Plastic Surgery device with product code NAD cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K831611 · Carapac Systems, Inc. · General & Plastic Surgery device
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Jun 1983
Decision
32d
Days
Class 1
Risk

K831611 is an FDA 510(k) clearance for the UNI-THANE. Classified as Dressing, Wound, Occlusive (product code NAD), Class I - General Controls.

Submitted by Carapac Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 20, 1983 after a review of 32 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4020 - 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 Carapac Systems, Inc. devices

FDA 510(k) Submission Details - K831611

510(k) Number K831611 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 1983
Decision Date June 20, 1983
Days to Decision 32 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
83d faster than avg
Panel avg: 115d · This submission: 32d
Pathway characteristics
Predicate-based equivalence.

NAD Device Classification - Class 1, General Controls

Product Code NAD Dressing, Wound, Occlusive
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4020
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 - NAD Dressing, Wound, Occlusive

All 56
Devices cleared under the same product code (NAD) and FDA review panel - the closest regulatory comparables to K831611.
ACU-DERM TRANSPARENT WOUND DRESSING
K842186 · Acme United Corp. · Aug 1984
ELASTIC BREATHABLE OVER-WRAP BANDAGE
K833729 · American Medical Disposable, Inc. · Dec 1983
LASTOBAND ADHESIVE BANDAGES
K831454 · Smith & Nephew, Inc. · Oct 1983
ENSURE DRESSING
K830593 · Warner-Lambert Co. · Apr 1983
CHESEBROUGH-POND'S MULTILAYER ELASTIC
K823852 · Chesebrough-Pond'S U.S.A. Co. · Mar 1983
ADHESIVE WOUND COVER FILM
K822080 · Hollister, Inc. · Oct 1982