Cleared Traditional

K904694 - CUSTOMED ANGIODRAPE PACK FEMORAL

K904694 is an FDA 510(k) clearance for CUSTOMED ANGIODRAPE PACK FEMORAL, manufactured by Customed, Inc.. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K904694 · Customed, Inc. · General Hospital
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Jan 1991
Decision
78d
Days
Class 2
Risk

K904694 is an FDA 510(k) clearance for the CUSTOMED ANGIODRAPE PACK FEMORAL. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Customed, Inc. (Carolina Puerto Rico, US). The FDA issued a Cleared decision on January 2, 1991 after a review of 78 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 Customed, Inc. devices

FDA 510(k) Submission Details - K904694

510(k) Number K904694 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received October 16, 1990
Decision Date January 02, 1991
Days to Decision 78 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 129d · This submission: 78d
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 202
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K904694.
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
ORION STERILE OR TOWELS
K903117 · Orion Life Systems, Inc. · Dec 1990
QUALTEX SURGICAL DRAPE
K904960 · Deroyal Industries, Inc. · Dec 1990
CUSTOMED CYSTO PACK II
K901705 · Customed, Inc. · Oct 1990