510(k) · Cleared
ClearedFlight Sock
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ssl Americas, Inc. · DWL Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)
Cleared on Mar 11, 2004 as substantially equivalent to K830696 (Futuro Div. Jung Corp., 1983) and 1 other predicate after a 28-day review. Its family tree reaches back 2 generations to 1995. 5 later devices descend from it.
- Decided
- Mar 11, 2004
- Review
- 28 days
- Class
- Class II
- Product code
- DWL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K955138 (1995). 3 ancestors in all, the oldest K830696 (1983). 5 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK955138 Anti-EM/GP StockingsJobst Institute, Inc. · 1995
- 1 generation backK032325 Jobst Travel SocksBsn-Jobst, Inc. · 2003
- This deviceK040353 Flight SockSsl Americas, Inc. · 2004
- Descendant · cites it directly · 4 of its ownK091141 Therafirm Anti-Embolism Stockings, Therafirm Men's and Women's…Knit-Rite, Inc. · 2009
- Descendant · 2 generations on · 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 · 3 generations on · 0 of its ownK123085 Futuro (TM) Travel Knee-Highs; Futuro (TM) Travel Socks; Futuro (TM)…3M Company · 2012
- Descendant · 2 generations on · 0 of its ownK101224 Saphenamedical Anti-Embolism StockingsGriffiths and Nielsen, Ltd. · 2010
Most influential descendants
Showing 5 of 5 · See all- K091141Therafirm Anti-Embolism Stockings, Therafirm Men's and Women's Trouser SocksKnit-Rite, Inc. · 2009 · cites it directly4descendants
- K101906Shape to Fit Compression WearTsung Hau Technology Co., Ltd. · 2010 · 2 generations on1descendant
- 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 · 3 generations on0descendants
- K101224Saphenamedical Anti-Embolism StockingsGriffiths and Nielsen, Ltd. · 2010 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K955138 | Anti-EM/GP Stockings | Jobst Institute, Inc. | 1995 | — |
| −1 | K032325 | Jobst Travel Socks | Bsn-Jobst, Inc. | 2003 | — |
| 0 (this device) | 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 | — |
| +2 | 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 | — |
| +3 | K123085 | Futuro (TM) Travel Knee-Highs; Futuro (TM) Travel Socks; Futuro (TM) Travel… | 3M Company | 2012 | — |
| +2 | 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 | 2 | 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 |
|---|---|---|---|
| * | K830696 | Venes Anti Embolism StockingsSummary page 1…e: Medical Support Stocking Classification: General Hospital and Personal Use Therapeutic Devices ILlC Predicate Devices Venes Anti Embolism Stockings (K830696) Jobst Travel Sock (K032325) ll.1D Device Description SSL's Medical Support Stocking is a compression stocking… | 1983 |
| * | K032325 | Jobst Travel SocksSummary page 1…Classification: General Hospital and Personal Use Therapeutic Devices ILlC Predicate Devices Venes Anti Embolism Stockings (K830696) Jobst Travel Sock (K032325) ll.1D Device Description SSL's Medical Support Stocking is a compression stocking in the 14 - l7mmHg range. I… | 2003 |
What descends from it? (5)
2 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 9 years and passes through 3 companies; a new generation was cleared every 7.7 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K091141 (Knit-Rite, Inc., 2009) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K830696.
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.
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 for long distance travelers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040353 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040353: Flight Sock.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040353
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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