Cleared Traditional

K843260 - ANGIOSYS FEMORAL ANGIOGRAPHY DRAPE

K843260 is an FDA 510(k) clearance for ANGIOSYS FEMORAL ANGIOGRAPHY DRAPE, manufactured by Angiosystems, Inc.. The device is a Class 2 General Hospital device with 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

FDA 510(k) Submission Details - K843260

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.

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 276
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K843260.
PMS DRAPE PACK
K844465 · Professional Medical Services · Dec 1984
ELASTIC STYLE IMPERVIOUS ORTHOPEDIC STOCKINET
K844199 · Kleen Test Products · Nov 1984
DRAPE SURGICAL UTILITY DRAPE STERILE
K843496 · Busse Hospital Disposables, Inc. · Oct 1984
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