Cleared Traditional

K905466 - STERILE DISPOSABLE SURGICAL DRAPE/ABDOMINAL DRAPE

K905466 is an FDA 510(k) clearance for STERILE DISPOSABLE SURGICAL DRAPE/ABDOM..., 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 68-day FDA review.

K905466 · Angiosystems, Inc. · General Hospital
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Feb 1991
Decision
68d
Days
Class 2
Risk

K905466 is an FDA 510(k) clearance for the STERILE DISPOSABLE SURGICAL DRAPE/ABDOMINAL DRAPE. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Angiosystems, Inc. (Great Neck, US). The FDA issued a Cleared decision on February 11, 1991 after a review of 68 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 - K905466

510(k) Number K905466 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1990
Decision Date February 11, 1991
Days to Decision 68 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
61d faster than avg
Panel avg: 129d · This submission: 68d
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 K905466.
DISPOSABLE O.R. TOWEL
K912110 · American Threshold Industries, Inc. · Jul 1991
PURITAS 100% COTTON ABSORB OPER ROOM SURG TOWELS
K912542 · Puritas Health Care, Inc. · Jul 1991
QUALTEX SURGICAL DRAPE
K910495 · Deroyal Industries, Inc. · Feb 1991
CUSTOMED CARDIOVASCULAR PACK
K904693 · Customed, Inc. · Jan 1991
CUSTOMED ANGIODRAPE PACK FEMORAL
K904694 · Customed, Inc. · Jan 1991
ORION STERILE OR TOWELS
K903117 · Orion Life Systems, Inc. · Dec 1990