Cleared Traditional

K904693 - CUSTOMED CARDIOVASCULAR PACK (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K904693 · Customed, Inc. · General Hospital
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Jan 1991
Decision
78d
Days
Class 2
Risk

K904693 is an FDA 510(k) clearance for the CUSTOMED CARDIOVASCULAR PACK. 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

Submission Details

510(k) Number K904693 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
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 128d · This submission: 78d
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.