Cleared Traditional

K122485 - ENCIRCLE COMPRESSION THERAPY STOCKING

K122485 is the FDA 510(k) clearance for ENCIRCLE COMPRESSION THERAPY STOCKING by Encircle Medical Devices , Ltd.. It is a Class 2 General Hospital device (product code DWL) cleared through the Traditional 510(k) pathway after a 252-day FDA review.

K122485 · Encircle Medical Devices , Ltd. · General Hospital
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Apr 2013
Decision
252d
Days
Class 2
Risk

K122485 is an FDA 510(k) clearance for the ENCIRCLE COMPRESSION THERAPY STOCKING. Classified as Stocking, Medical Support (to Prevent Pooling Of Blood In Legs) (product code DWL), Class II - Special Controls.

Submitted by Encircle Medical Devices , Ltd. (Palos Verdes Estates, US). The FDA issued a Cleared decision on April 23, 2013 after a review of 252 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.

View all Encircle Medical Devices , Ltd. devices

Submission Details

510(k) Number K122485 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2012
Decision Date April 23, 2013
Days to Decision 252 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
123d slower than avg
Panel avg: 129d · This submission: 252d
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 K122485.
MEDLINE ANTI-EMBOLISM STOCKING
K141127 · Medline Industries, Inc. · Aug 2014
FUTURO (TM) TRAVEL KNEE-HIGHS
K123085 · 3M Company · Dec 2012
CURAD COMPRESSION HOSIERY
K112769 · Medline Industries, Inc. · Mar 2012
ANTI-EMBOLISM STOCKINGS, MODELS 71055-00000-02, 71057-00000-02, 71059-00000-02, 71064-00000-02 & 71065-00000-02
K090921 · Beiersdorf, Inc. · Dec 2009
BOEHRINGER LABORATORIES PNEUMATIC AMBULATORY COMPRESSION SYSTEM 8200 SERIES
K020538 · Boehringer Laboratories · May 2002
KENDALL HOME RX THERAPEUTIC STOCKING
K925417 · Kendall Healthcare Products Co. Div.Of Tyco Health · Jun 1993