# K101224: Saphenamedical Anti-Embolism Stockings

- Pathway: 510(k) (Traditional)
- Applicant: Griffiths and Nielsen, Ltd.
- Decided: Dec 3, 2010 after 214 days
- Product code: DWL (Stocking, Medical Support (To Prevent Pooling Of Blood In Legs))
- Device class: 2
- Regulation: 21 CFR 880.5780
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K955138 (1995). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090921: Anti-Embolism Stockings, Models 71055-00000-02, 71057-00000-02, 71059-00000-02, 71064-00000-02 & 71065-00000-02, Beiersdorf, Inc. (2009) Summary page 2.
- K091141: Therafirm Anti-Embolism Stockings, Therafirm Men's and Women's Trouser Socks, Knit-Rite, Inc. (2009) Summary page 3.
- K925417: Kendall Home RX Therapeutic Stocking, Kendall Healthcare Products Co. Div.Of Tyco Health (1993) Summary page 2.
- (no number) CAP anti-embolism stockings: named in the summary without a submission number

## Indications for use
SaphenaMEDICAL Anti-Embolism Stockings are intended to: * Help to prevent the pooling of blood in the legs by applying controlled pressure to the legs. * Help to prevent Deep Vein Thrombosis (DVT) and also edema and leg discomfort, individuals subjected to immobility.

Source page: https://510kreport.com/device/K101224
Methodology: https://510kreport.com/methodology