Cleared Traditional

K954212 - CONTAMINATION CONTAINMENT DRAPE

K954212 is an FDA 510(k) clearance for CONTAMINATION CONTAINMENT DRAPE, manufactured by Engineering Controls For Medicine. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K954212 · Engineering Controls For Medicine · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1995
Decision
46d
Days
Class 2
Risk

K954212 is an FDA 510(k) clearance for the CONTAMINATION CONTAINMENT DRAPE. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Engineering Controls For Medicine (Fort Worth, US). The FDA issued a Cleared decision on October 23, 1995 after a review of 46 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 Engineering Controls For Medicine devices

FDA 510(k) Submission Details - K954212

510(k) Number K954212 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 1995
Decision Date October 23, 1995
Days to Decision 46 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 129d · This submission: 46d
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 286
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K954212.
VOLMED OPERATION DRAPE
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DEROYAL SURGICAL INSTRUMENT DRAPE
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OREX(R) O.R EQUIPMENT DRAPES
K945755 · Thantex Specialties, Inc. · May 1995
REMINGTON MEDICAL DISPOSABLE FLUORO/EQUIPMENT COVER MODEL RMI8
K946060 · Remington Medical, Inc. · Apr 1995