Cleared Traditional

K931091 - DISPOSABLE AMA STERILE DRAPE SHEET, CAT. NO. 5252 (FDA 510(k) Clearance)

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

K931091 · Alliance Medical, Inc. · General Hospital
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Feb 1994
Decision
337d
Days
Class 2
Risk

K931091 is an FDA 510(k) clearance for the DISPOSABLE AMA STERILE DRAPE SHEET, CAT. NO. 5252. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Alliance Medical, Inc. (Santa Ynez, US). The FDA issued a Cleared decision on February 3, 1994 after a review of 337 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Alliance Medical, Inc. devices

Submission Details

510(k) Number K931091 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1993
Decision Date February 03, 1994
Days to Decision 337 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
209d slower than avg
Panel avg: 128d · This submission: 337d
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.