Cleared Traditional

K111662 - VENOTRAIN CURAFLOW

K111662 is an FDA 510(k) clearance for VENOTRAIN CURAFLOW, manufactured by Bauerfeind AG. The device is a Class 2 General Hospital device with product code DWL cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K111662 · Bauerfeind AG · General Hospital
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Oct 2011
Decision
112d
Days
Class 2
Risk

K111662 is an FDA 510(k) clearance for the VENOTRAIN CURAFLOW. Classified as Stocking, Medical Support (to Prevent Pooling Of Blood In Legs) (product code DWL), Class II - Special Controls.

Submitted by Bauerfeind AG (Zeulenroda-Triebes, DE). The FDA issued a Cleared decision on October 4, 2011 after a review of 112 days - within the typical 510(k) review window.

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.

View all Bauerfeind AG devices

FDA 510(k) Submission Details - K111662

510(k) Number K111662 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 2011
Decision Date October 04, 2011
Days to Decision 112 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
17d faster than avg
Panel avg: 129d · This submission: 112d
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 9
Devices cleared under the same product code (DWL) and FDA review panel - the closest regulatory comparables to K111662.
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BOEHRINGER LABORATORIES PNEUMATIC AMBULATORY COMPRESSION SYSTEM 8200 SERIES
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K925417 · Kendall Healthcare Products Co. Div.Of Tyco Health · Jun 1993