Cleared Traditional

K121436 - DAS MEDICAL EQUIPMENT DRAPES

K121436 is an FDA 510(k) clearance for DAS MEDICAL EQUIPMENT DRAPES, manufactured by Das Medical, LLC. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 387-day FDA review.

K121436 · Das Medical, LLC · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2013
Decision
387d
Days
Class 2
Risk

K121436 is an FDA 510(k) clearance for the DAS MEDICAL EQUIPMENT DRAPES. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Das Medical, LLC (Columbus, US). The FDA issued a Cleared decision on June 6, 2013 after a review of 387 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.

FDA 510(k) Submission Details - K121436

510(k) Number K121436 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2012
Decision Date June 06, 2013
Days to Decision 387 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
258d slower than avg
Panel avg: 129d · This submission: 387d
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 349
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K121436.
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K121436 · DAS MEDICAL EQUIPMENT DRAPES
Download PDF FDA Summary Das Medical, LLC