510(k) · Cleared
ClearedAnti-Embolism Stockings, Models 71055-00000-02, 71057-00000-02, 71059-00000-02, 71064-00000-02 & 71065-00000-02
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beiersdorf, Inc. · DWL Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)
Cleared on Dec 18, 2009 as substantially equivalent to K040353 (Ssl Americas, Inc., 2004) and 4 other predicates after a 261-day review. Its family tree reaches back 4 generations to 1995. 1 later device descends from it.
- Decided
- Dec 18, 2009
- Review
- 261 days
- Class
- Class II
- Product code
- DWL
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 4 generations to K955138 (1995). 6 ancestors in all, the oldest K830696 (1983). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK955138 Anti-EM/GP StockingsJobst Institute, Inc. · 1995
- 3 generations backK032325 Jobst Travel SocksBsn-Jobst, Inc. · 2003
- 2 generations backK040353 Flight SockSsl Americas, Inc. · 2004
- 1 generation backK091141 Therafirm Anti-Embolism Stockings, Therafirm Men's and Women's…Knit-Rite, Inc. · 2009
- This deviceK090921 Anti-Embolism Stockings, Models 71055-00000-02, 71057-00000-02…Beiersdorf, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK101224 Saphenamedical Anti-Embolism StockingsGriffiths and Nielsen, Ltd. · 2010
Most influential descendants
Showing 1 of 1 · See all- K101224Saphenamedical Anti-Embolism StockingsGriffiths and Nielsen, Ltd. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K955138 | Anti-EM/GP Stockings | Jobst Institute, Inc. | 1995 | — |
| −3 | K032325 | Jobst Travel Socks | Bsn-Jobst, Inc. | 2003 | — |
| −2 | K040353 | Flight Sock | Ssl Americas, Inc. | 2004 | — |
| −1 | K091141 | Therafirm Anti-Embolism Stockings, Therafirm Men's and Women's Trouser Socks | Knit-Rite, Inc. | 2009 | — |
| 0 (this device) | K090921 | Anti-Embolism Stockings, Models 71055-00000-02, 71057-00000-02… | Beiersdorf, Inc. | 2009 | — |
| +1 | 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 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 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? (7)
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 |
|---|---|---|---|
| * | K040353 | Flight SockSummary page 2…ntial December 16, 2009 Pagel7ofl16 Predicate Devices: K040353 Flight Sock K032325 Jobst Travel Socks… | 2004 |
| * | K032325 | Jobst Travel SocksSummary page 2…Pagel7ofl16 Predicate Devices: K040353 Flight Sock K032325 Jobst Travel Socks K925643 RX FIT Medical Stockings… | 2003 |
| * | K925643 | RX Fit Medical StockingsSummary page 2…evices: K040353 Flight Sock K032325 Jobst Travel Socks K925643 RX FIT Medical Stockings K830696 VENES Anti-Embolism Stocking… | 1993 |
| * | K830696 | Venes Anti Embolism StockingsSummary page 2…K032325 Jobst Travel Socks K925643 RX FIT Medical Stockings K830696 VENES Anti-Embolism Stocking K091 141 Therafirm Anti-Embolism Stockings and… | 1983 |
| * | K091141 | Therafirm Anti-Embolism Stockings, Therafirm Men's and Women's Trouser Socks Cleared while this submission was under review Summary page 2…K925643 RX FIT Medical Stockings K830696 VENES Anti-Embolism Stocking K091 141 Therafirm Anti-Embolism Stockings and Therafirm Men's Trouser Socks and Women's Trous… | 2009 |
| * | — | Kendall T.ED. Anti-Embolism Stockings Named without a submission number | |
| * | — | TRUFORM Anti-Embolism Stockings Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101224 | Saphenamedical Anti-Embolism Stockings | 2010 | 0 |
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 14 years and passes through 5 companies; a new generation was cleared every 5.4 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K101224 (Griffiths and Nielsen, Ltd., 2010) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K040353.
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. 2009, 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?
Help prevent edema and leg discomfort, and help prevent deep vein thrombosis (DVT) in individuals subjected to immobility.
Over-the-Counter (OTC) Use
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090921 · printed Nov 5, 2026
Cite this page
510(k) Report. “K090921: Anti-Embolism Stockings, Models 71055-00000-02, 71057-00000-02, 71059-00000-02, 71064-00000-02 & 71065-00000-02.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K090921
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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