Cleared Traditional

K843260 - ANGIOSYS FEMORAL ANGIOGRAPHY DRAPE

K843260 is the FDA 510(k) clearance for ANGIOSYS FEMORAL ANGIOGRAPHY DRAPE by Angiosystems, Inc.. It is a Class 2 General Hospital device (product code KKX) cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K843260 · Angiosystems, Inc. · General Hospital
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Sep 1984
Decision
32d
Days
Class 2
Risk

K843260 is an FDA 510(k) clearance for the ANGIOSYS FEMORAL ANGIOGRAPHY DRAPE. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Angiosystems, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 21, 1984 after a review of 32 days - a notably fast clearance cycle.

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: 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 Angiosystems, Inc. devices

Submission Details

510(k) Number K843260 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1984
Decision Date September 21, 1984
Days to Decision 32 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
97d faster than avg
Panel avg: 129d · This submission: 32d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 65
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K843260.
TUBULAR ORTHO. STOCKINETTE W/ANTIMICROBIAL AGENT
K860326 · Deroyal Industries, Inc. · Feb 1986
ABCO DRAPES/TOWELS
K851314 · Abco Dealers, Inc. · May 1985
SURGICAL DRAPES
K844802 · Procter & Gamble Mfg. Co. · Jan 1985
SPUNGARD & SURG. DRAPES-GOWNS & PACKS
K842115 · Kimberly-Clark Corp. · Jun 1984
SINGLE-USE SURGICAL DRAPES
K833877 · Procter & Gamble Mfg. Co. · Jan 1984
LIGHT HANDLE COVER
K832278 · Concept, Inc. · Sep 1983