510(k) · Cleared
ClearedTherafirm Anti-Embolism Stockings, Therafirm Men's and Women's Trouser Socks
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Knit-Rite, Inc. · DWL Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)
Cleared on Jul 24, 2009 as substantially equivalent to K032325 (Bsn-Jobst, Inc., 2003) and 1 other predicate after a 95-day review. Its family tree reaches back 3 generations to 1995. 4 later devices descend from it.
- Decided
- Jul 24, 2009
- Review
- 95 days
- Class
- Class II
- Product code
- DWL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K955138 (1995). 4 ancestors in all, the oldest K830696 (1983). 4 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK955138 Anti-EM/GP StockingsJobst Institute, Inc. · 1995
- 2 generations backK032325 Jobst Travel SocksBsn-Jobst, Inc. · 2003
- 1 generation backK040353 Flight SockSsl Americas, Inc. · 2004
- This deviceK091141 Therafirm Anti-Embolism Stockings, Therafirm Men's and Women's…Knit-Rite, Inc. · 2009
- Descendant · cites it directly · 1 of its ownK101906 Shape to Fit Compression WearTsung Hau Technology Co., Ltd. · 2010
- Descendant · cites it directly · 1 of its ownK090921 Anti-Embolism Stockings, Models 71055-00000-02, 71057-00000-02…Beiersdorf, Inc. · 2009
- Descendant · 2 generations on · 0 of its ownK123085 Futuro (TM) Travel Knee-Highs; Futuro (TM) Travel Socks; Futuro (TM)…3M Company · 2012
- Descendant · cites it directly · 0 of its ownK101224 Saphenamedical Anti-Embolism StockingsGriffiths and Nielsen, Ltd. · 2010
Most influential descendants
Showing 4 of 4 · See all- K101906Shape to Fit Compression WearTsung Hau Technology Co., Ltd. · 2010 · cites it directly1descendant
- K090921Anti-Embolism Stockings, Models 71055-00000-02, 71057-00000-02, 71059-00000-02…Beiersdorf, Inc. · 2009 · cites it directly1descendant
- K123085Futuro (TM) Travel Knee-Highs; Futuro (TM) Travel Socks; Futuro (TM) Travel Stockings…3M Company · 2012 · 2 generations on0descendants
- 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 |
|---|---|---|---|---|---|
| −3 | K955138 | Anti-EM/GP Stockings | Jobst Institute, Inc. | 1995 | — |
| −2 | K032325 | Jobst Travel Socks | Bsn-Jobst, Inc. | 2003 | — |
| −1 | K040353 | Flight Sock | Ssl Americas, Inc. | 2004 | — |
| 0 (this device) | K091141 | Therafirm Anti-Embolism Stockings, Therafirm Men's and Women's Trouser Socks | Knit-Rite, Inc. | 2009 | — |
| +1 | K101906 | Shape to Fit Compression Wear | Tsung Hau Technology Co., Ltd. | 2010 | — |
| +1 | K090921 | Anti-Embolism Stockings, Models 71055-00000-02, 71057-00000-02… | Beiersdorf, Inc. | 2009 | — |
| +2 | K123085 | Futuro (TM) Travel Knee-Highs; Futuro (TM) Travel Socks; Futuro (TM) Travel… | 3M Company | 2012 | — |
| +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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 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? (2)
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 |
|---|---|---|---|
| * | K032325 | Jobst Travel SocksSummary page 1…Therafirm division manufactures Men’s Trouser Socks and Women’s Trouser Socks that fall in to this category, and they are substantially equivalent to Jobst Travel Socks (K032325) and SSL Americas Flight Sock (K040353). Therafirm Trouser Socks and their substantial equivalents are knit on circular knit mac… | 2003 |
| * | K040353 | Flight SockSummary page 1…rouser Socks and Women’s Trouser Socks that fall in to this category, and they are substantially equivalent to Jobst Travel Socks (K032325) and SSL Americas Flight Sock (K040353). Therafirm Trouser Socks and their substantial equivalents are knit on circular knit machines. These products are made with nyl… | 2004 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 4 companies; a new generation was cleared every 5.4 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K101906 (Tsung Hau Technology Co., Ltd., 2010) has gone furthest, with 1 descendant of its own.
- 6 other devices also cite its predicate K032325.
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 in individuals subjected to immobility.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K091141 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091141: Therafirm Anti-Embolism Stockings, Therafirm Men's and Women's Trouser Socks.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091141
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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