Cleared Traditional

K831282 - BANDAGE COMPRESS

K831282 is an FDA 510(k) clearance for BANDAGE COMPRESS, manufactured by Pac-Kit Safety Equipment Co.. The device is a Class 1 General & Plastic Surgery device with product code NAB cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K831282 · Pac-Kit Safety Equipment Co. · General & Plastic Surgery device
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Aug 1983
Decision
112d
Days
Class 1
Risk

K831282 is an FDA 510(k) clearance for the BANDAGE COMPRESS. Classified as Gauze / Sponge,nonresorbable For External Use (product code NAB), Class I - General Controls.

Submitted by Pac-Kit Safety Equipment Co. (Mchenry, US). The FDA issued a Cleared decision on August 12, 1983 after a review of 112 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4014 - 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 Pac-Kit Safety Equipment Co. devices

FDA 510(k) Submission Details - K831282

510(k) Number K831282 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1983
Decision Date August 12, 1983
Days to Decision 112 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
3d faster than avg
Panel avg: 115d · This submission: 112d
Pathway characteristics
Predicate-based equivalence.

NAB Device Classification - Class 1, General Controls

Product Code NAB Gauze / Sponge,nonresorbable For External Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4014
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 - NAB Gauze / Sponge,nonresorbable For External Use

All 34
Devices cleared under the same product code (NAB) and FDA review panel - the closest regulatory comparables to K831282.
TRICOTEX WOUND CONTACT LAYER DRESSING
K864264 · Smith & Nephew, Inc. · Dec 1986
AN ODOR ABSORBENT BANDAGE
K833735 · American Medical Disposable, Inc. · Apr 1984
FEMORAL CANAL SPONGE
K831886 · Zimmer, Inc. · Sep 1983
NOVA GAUZE
K830473 · American Threshold Industries, Inc. · Apr 1983
COVER-ROLL STRETCH
K823879 · Beiersdorf, Inc. · Mar 1983
CONVERTORS DISPOSABLE DRESSING SPONGE
K822966 · American Hospital Supply Corp. · Nov 1982