Cleared Traditional

K860826 - VENOTRAIN COLOR COMPRESSION STOCKINGS &...

K860826 is the FDA 510(k) clearance for VENOTRAIN COLOR COMPRESSION STOCKINGS &... by Bauerfeind GmbH & Co.. It is a Class 2 General Hospital device (product code DWL) cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K860826 · Bauerfeind GmbH & Co. · General Hospital
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Jun 1986
Decision
106d
Days
Class 2
Risk

K860826 is an FDA 510(k) clearance for the VENOTRAIN COLOR COMPRESSION STOCKINGS & PANTYHOSE. Classified as Stocking, Medical Support (to Prevent Pooling Of Blood In Legs) (product code DWL), Class II - Special Controls.

Submitted by Bauerfeind GmbH & Co. (Marietta, US). The FDA issued a Cleared decision on June 18, 1986 after a review of 106 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 GmbH & Co. devices

Submission Details

510(k) Number K860826 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1986
Decision Date June 18, 1986
Days to Decision 106 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 129d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 K860826.
KENDALL HOME RX THERAPEUTIC STOCKING
K925417 · Kendall Healthcare Products Co. Div.Of Tyco Health · Jun 1993
SCD THERAPEUTIC STOCKING SYSTEM
K902497 · Kendall Healthcare Products Co. Div.Of Tyco Health · Aug 1990
ENHANCE SUPPORT HOSE
K873280 · Kimberly-Clark Corp. · Oct 1987
A.V.R. KNEE LENGTH THERAPEUTIC STOCK-
K832609 · The Kendal Co. · Sep 1983