Cleared Traditional

K101224 - SAPHENAMEDICAL ANTI-EMBOLISM STOCKINGS

K101224 is an FDA 510(k) clearance for SAPHENAMEDICAL ANTI-EMBOLISM STOCKINGS, manufactured by Griffiths and Nielsen, Ltd.. The device is a Class 2 General Hospital device with product code DWL cleared through the Traditional 510(k) pathway after a 214-day FDA review.

K101224 · Griffiths and Nielsen, Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2010
Decision
214d
Days
Class 2
Risk

K101224 is an FDA 510(k) clearance for the SAPHENAMEDICAL ANTI-EMBOLISM STOCKINGS. Classified as Stocking, Medical Support (to Prevent Pooling Of Blood In Legs) (product code DWL), Class II - Special Controls.

Submitted by Griffiths and Nielsen, Ltd. (Horsham, West Sussex, GB). The FDA issued a Cleared decision on December 3, 2010 after a review of 214 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 - K101224

510(k) Number K101224 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 2010
Decision Date December 03, 2010
Days to Decision 214 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d slower than avg
Panel avg: 129d · This submission: 214d
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 K101224.
CURAD COMPRESSION HOSIERY
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K101906 · Tsung Hau Technology Co., Ltd. · Sep 2010
1-M GRADUATED COMPRESSION ANTI-EMBOLISM STOCKING, MODEL SS-811, SS-508, SS-613
K092892 · I-Ming Sanitary Materials Co., Ltd. · Aug 2010
ANTI-EMBOLISM STOCKINGS, MODELS 71055-00000-02, 71057-00000-02, 71059-00000-02, 71064-00000-02 & 71065-00000-02
K090921 · Beiersdorf, Inc. · Dec 2009
K101224 · SAPHENAMEDICAL ANTI-EMBOLISM STOCKINGS
Download PDF FDA Summary Griffiths and Nielsen…