Cleared Traditional

K141127 - MEDLINE ANTI-EMBOLISM STOCKING

K141127 is an FDA 510(k) clearance for MEDLINE ANTI-EMBOLISM STOCKING, 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 112-day FDA review.

K141127 · Medline Industries, Inc. · General Hospital
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Aug 2014
Decision
112d
Days
Class 2
Risk

K141127 is an FDA 510(k) clearance for the MEDLINE ANTI-EMBOLISM STOCKING. 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 August 21, 2014 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.

FDA 510(k) Submission Details - K141127

510(k) Number K141127 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2014
Decision Date August 21, 2014
Days to Decision 112 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
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 44
Devices cleared under the same product code (DWL) and FDA review panel - the closest regulatory comparables to K141127.
BELLAVAR / CUSTOM SEAMLESS SOFT (A.K.A. COMTESSE)
K131496 · Bsn Medical, Inc. · Jul 2013
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BOSSONG HOSIERY MEDICAL COMPRESSION STOCKINGS 8-15 MMHG, BOSSONG HOSIERY ANTI-EMBOLISM STOCKINGS 10-20 MMHG, BOSSONG HOS
K123820 · Bossong Hosiery Mills, Inc. · Apr 2013
FUTURO (TM) TRAVEL KNEE-HIGHS
K123085 · 3M Company · Dec 2012
DR. SCHOLL'S COMPRESSION SOCKS
K123398 · Renfro Corporation · Dec 2012
ELVAREX/ELVAREX SOFT/ELVAREX SOFT SEAMLESS
K123561 · Bsn Medical, Inc. · Dec 2012
K141127 · MEDLINE ANTI-EMBOLISM STOCKING
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