Cleared Traditional

K112769 - CURAD COMPRESSION HOSIERY

K112769 is an FDA 510(k) clearance for CURAD COMPRESSION HOSIERY, manufactured by Medline Industries, Inc.. The device is a Class 2 General Hospital device with product code DWL cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K112769 · Medline Industries, Inc. · General Hospital
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Mar 2012
Decision
160d
Days
Class 2
Risk

K112769 is an FDA 510(k) clearance for the CURAD COMPRESSION HOSIERY. Classified as Stocking, Medical Support (to Prevent Pooling Of Blood In Legs) (product code DWL), Class II - Special Controls.

Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on March 1, 2012 after a review of 160 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5780 - 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. Standard predicate reliance. 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 - K112769

510(k) Number K112769 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2011
Decision Date March 01, 2012
Days to Decision 160 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 129d · This submission: 160d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DWL Device Classification - Class 2, Special Controls

Product Code DWL Stocking, Medical Support (to Prevent Pooling Of Blood In Legs)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5780
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 - DWL Stocking, Medical Support (to Prevent Pooling Of Blood In Legs)

All 50
Devices cleared under the same product code (DWL) and FDA review panel - the closest regulatory comparables to K112769.
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K112769 · CURAD COMPRESSION HOSIERY
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