510(k) · Cleared
ClearedSaphenamedical Anti-Embolism Stockings
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Griffiths and Nielsen, Ltd. · DWL Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)
Cleared on Dec 3, 2010 as substantially equivalent to K090921 (Beiersdorf, Inc., 2009) and 2 other predicates after a 214-day review. Its family tree reaches back 5 generations to 1995.
- Decided
- Dec 3, 2010
- Review
- 214 days
- Class
- Class II
- Product code
- DWL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K955138 (1995). 8 ancestors in all, the oldest K830696 (1983). No later device cites it as a predicate yet.
- Root · 5 generations backK955138 Anti-EM/GP StockingsJobst Institute, Inc. · 1995
- 4 generations backK032325 Jobst Travel SocksBsn-Jobst, Inc. · 2003
- 3 generations backK040353 Flight SockSsl Americas, Inc. · 2004
- 2 generations backK091141 Therafirm Anti-Embolism Stockings, Therafirm Men's and Women's…Knit-Rite, Inc. · 2009
- 1 generation backK090921 Anti-Embolism Stockings, Models 71055-00000-02, 71057-00000-02…Beiersdorf, Inc. · 2009
- This deviceK101224 Saphenamedical Anti-Embolism StockingsGriffiths and Nielsen, Ltd. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K955138 | Anti-EM/GP Stockings | Jobst Institute, Inc. | 1995 | — |
| −4 | K032325 | Jobst Travel Socks | Bsn-Jobst, Inc. | 2003 | — |
| −3 | K040353 | Flight Sock | Ssl Americas, Inc. | 2004 | — |
| −2 | K091141 | Therafirm Anti-Embolism Stockings, Therafirm Men's and Women's Trouser Socks | Knit-Rite, Inc. | 2009 | — |
| −1 | K090921 | Anti-Embolism Stockings, Models 71055-00000-02, 71057-00000-02… | Beiersdorf, Inc. | 2009 | — |
| 0 (this device) | K101224 | Saphenamedical Anti-Embolism Stockings | Griffiths and Nielsen, Ltd. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1993 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DWL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K090921 | Anti-Embolism Stockings, Models 71055-00000-02, 71057-00000-02, 71059-00000-02…Summary page 2…ct to the intended userindications for use, and the technological characteristics: Beiersdorf INC. Anti-Embolism Stockings K090921 Knit-Rite, INC. Therafirm Anti-Embolism Stockings KO091141 TycoLL Helhae Grisoup LP… | 2009 |
| * | K091141 | Therafirm Anti-Embolism Stockings, Therafirm Men's and Women's Trouser SocksSummary page 3…Embolism Stockings Embolism Stockings stockings Name Stockings K090921 k0911411 951 GRequitremetd… | 2009 |
| * | K925417 | Kendall Home RX Therapeutic StockingSummary page 2…Therafirm Anti-Embolism Stockings KO091141 TycoLL Helhae Grisoup LP Kendall T.ED. Anti-Embolism Stockings K92541 7 Approved Prior to 510k Carolon CO… | 1993 |
| * | — | CAP anti-embolism stockings Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 6 companies; a new generation was cleared every 11 months on median.
- None of the 8 ancestors has a recall.
How does its category compare?
All DWL devicesDWL Stocking, Medical Support (To Prevent Pooling Of Blood In Legs): FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · DWL
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · DWL
111in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DWL
No recall names DWL since 2007.
Adverse event reports per year · DWL
2in 2025
MAUDE reports naming product code DWL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 3 |
| 2010 | 3 | 214 | 0 | 7 |
| 2011 | 2 | — | 0 | 4 |
| 2012 | 5 | 43 | 0 | 10 |
| 2013 | 3 | 111 | 0 | 4 |
| 2014 | 1 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 4 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101224 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101224: Saphenamedical Anti-Embolism Stockings.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101224
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026