Cleared Traditional

K833122 - BURLINGTON ANTIMICROBIAL STOCKINEETTE

K833122 is an FDA 510(k) clearance for BURLINGTON ANTIMICROBIAL STOCKINEETTE, manufactured by Balfour, Inc.. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K833122 · Balfour, Inc. · General Hospital
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Jan 1984
Decision
134d
Days
Class 2
Risk

K833122 is an FDA 510(k) clearance for the BURLINGTON ANTIMICROBIAL STOCKINEETTE. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Balfour, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 25, 1984 after a review of 134 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4370 - the FDA general hospital 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 Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Balfour, Inc. devices

FDA 510(k) Submission Details - K833122

510(k) Number K833122 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 1983
Decision Date January 25, 1984
Days to Decision 134 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 129d · This submission: 134d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KKX Device Classification - Class 2, Special Controls

Product Code KKX Drape, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4370
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - KKX Drape, Surgical

All 275
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K833122.
ACU-DERM TRANSPARENT INCISE DRAPE
K841735 · Acme United Corp. · Aug 1984
SPUNGARD & SURG. DRAPES-GOWNS & PACKS
K842115 · Kimberly-Clark Corp. · Jun 1984
ANTIMICROBIAL INCISE DRAPE
K840957 · American Convertors Div., American Pharmaseal · Jun 1984
SINGLE-USE SURGICAL DRAPES
K833877 · Procter & Gamble Mfg. Co. · Jan 1984
LIGHT HANDLE COVER
K832278 · Concept, Inc. · Sep 1983
ISOVIS WOUND PROTECTOR
K832874 · Ritmed, Inc. · Sep 1983