Cleared Traditional

K853347 - MAI STERILE UTILITY DRAPE

K853347 is an FDA 510(k) clearance for MAI STERILE UTILITY DRAPE, manufactured by Medical Assoc. Intl., Inc.. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K853347 · Medical Assoc. Intl., Inc. · General Hospital
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Sep 1985
Decision
24d
Days
Class 2
Risk

K853347 is an FDA 510(k) clearance for the MAI STERILE UTILITY DRAPE. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Medical Assoc. Intl., Inc. (Topeka, US). The FDA issued a Cleared decision on September 5, 1985 after a review of 24 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 Medical Assoc. Intl., Inc. devices

FDA 510(k) Submission Details - K853347

510(k) Number K853347 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1985
Decision Date September 05, 1985
Days to Decision 24 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
105d faster than avg
Panel avg: 129d · This submission: 24d
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 293
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K853347.
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