510(k) · Cleared
ClearedSCD Express Portable Compression System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tyco Healthcare/Kendall · JOW Sleeve, Limb, Compressible
Cleared on Jun 28, 2004 as substantially equivalent to K992079 (The Kendall Company, L.P., 1999) and 1 other predicate after a 122-day review. Its family tree reaches back 1 generation to 1996. 38 later devices descend from it.
- Decided
- Jun 28, 2004
- Review
- 122 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K953648 (1996). 2 ancestors in all. 38 later devices descend from it, 9 citing it directly.
- Root · 1 generation backK953648 A-V Impulse System Model 6060Novamedix, Ltd. · 1996
- This deviceK040511 SCD Express Portable Compression SystemTyco Healthcare/Kendall · 2004
- Descendant · cites it directly · 11 of its ownK102737 Kendall SCD 700 Sequential Compression ControllerCovidien, LLC · 2010
- Descendant · cites it directly · 10 of its ownK112677 The Venous Assist SystemDaesung Maref Co., Ltd. · 2012
- Descendant · cites it directly · 6 of its ownK110977 VesoflowCaremed Supply, Inc. · 2011
- Descendant · 2 generations on · 5 of its ownK120944 Kendall SCD 700 Sequential Compression ControllerCovidien · 2012
- Descendant · 2 generations on · 4 of its ownK141064 Vesoflow Plus DVT Compression DeviceCaremed Supply, Inc. · 2014
Showing 5 of 38 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 38 · See all- K102737Kendall SCD 700 Sequential Compression ControllerCovidien, LLC · 2010 · cites it directly11descendants
- K112677The Venous Assist SystemDaesung Maref Co., Ltd. · 2012 · cites it directly10descendants
- K110977VesoflowCaremed Supply, Inc. · 2011 · cites it directly6descendants
- K120944Kendall SCD 700 Sequential Compression ControllerCovidien · 2012 · 2 generations on5descendants
- K141064Vesoflow Plus DVT Compression DeviceCaremed Supply, Inc. · 2014 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K953648 | A-V Impulse System Model 6060 | Novamedix, Ltd. | 1996 | — |
| 0 (this device) | K040511 | SCD Express Portable Compression System | Tyco Healthcare/Kendall | 2004 | — |
| +1 | K102737 | Kendall SCD 700 Sequential Compression Controller | Covidien, LLC | 2010 | — |
| +1 | K112677 | The Venous Assist System | Daesung Maref Co., Ltd. | 2012 | — |
| +1 | K110977 | Vesoflow | Caremed Supply, Inc. | 2011 | — |
| +2 | K120944 | Kendall SCD 700 Sequential Compression Controller | Covidien | 2012 | — |
| +2 | K141064 | Vesoflow Plus DVT Compression Device | Caremed Supply, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 5 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 4 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 4 | 0 |
| 2018 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 JOW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JOW device
- #1 K253555 Flexitouch® Plus Advanced Pneumatic…score 14.8 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K992079 | Kendall Model 7325 SCD Response Compression System, Model 7325Summary page 2…• Leg Ulcers * Venous Stasis / Venous Insufficiency 6. Product Comparison The SCD Expresstm Controller and the SCD Response-' Compression System (K992079) as well as the SCD Express T PCS Foot Cuff to the Novamedix AVlmpad (K953648) are substantially equivalent… | 1999 |
| * | K953648 | A-V Impulse System Model 6060Summary page 2…on The SCD Expresstm Controller and the SCD Response-' Compression System (K992079) as well as the SCD Express T PCS Foot Cuff to the Novamedix AVlmpad (K953648) are substantially equivalent M in intended use, function and mode of operation. 7. No… | 1996 |
What descends from it? (38)
See all 389 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102737 | Kendall SCD 700 Sequential Compression Controller | 2010 | 11 |
| K112677 | The Venous Assist System | 2012 | 10 |
| K110977 | Vesoflow | 2011 | 6 |
| K053575 | Hygia Health Services Reprocessed Kendall SCD Express Sleeves/Foot Cuffs | 2006 | 3 |
| K060049 | Reprocessed Compression Sleeves | 2006 | 1 |
| K163055 | Reprocessed Kendall SCD Express Foot Cuff | 2016 | 0 |
| K110358 | Venodyne V810 | 2011 | 0 |
| K101330 | Midwest Reprocessing Center Reprocessed SCD Express Sleeves/ Foot Cuffs, Midwest… | 2010 | 0 |
| K100306 | Kendall SCD Sequential Compression Comfort Sleeves | 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?
How does its category compare?
All JOW devicesJOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JOW
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JOW
168in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JOW
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JOW
24in 2025
MAUDE reports naming product code JOW, 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 | 6 | 66 | 0 | 12 |
| 2008 | 4 | 112 | 7 | 36 |
| 2009 | 3 | 84 | 0 | 45 |
| 2010 | 18 | 71 | 2 | 66 |
| 2011 | 11 | 104 | 3 | 50 |
| 2012 | 13 | 63 | 2 | 100 |
| 2013 | 17 | 94 | 0 | 169 |
| 2014 | 16 | 91 | 0 | 93 |
| 2015 | 10 | 160 | 0 | 137 |
| 2016 | 9 | 121 | 0 | 150 |
| 2017 | 9 | 116 | 1 | 149 |
| 2018 | 11 | 136 | 0 | 114 |
| 2019 | 11 | 88 | 1 | 102 |
| 2020 | 14 | 158 | 0 | 50 |
| 2021 | 16 | 132 | 0 | 34 |
| 2022 | 7 | 80 | 0 | 27 |
| 2023 | 6 | 160 | 0 | 57 |
| 2024 | 8 | 197 | 0 | 30 |
| 2025 | 7 | 168 | 0 | 24 |
| 2026 | 6 | 252 | 0 | — |
What is it indicated for?
The SCD EXPRESS*Compression System is designed to increase venous blood flow in at-risk patients in order to help prevent deep vein thrombosis and pulmonary embolism. The System consists of the Controller, the Tubing Sets (provided with the Controller) and single-patient use garments (purchased separately from this Controller). The garments, both leg sleeves and foot cuffs, compress the limbs to enhance venous blood movement. After the compression, the…
Read the full statement (135 words)
The SCD EXPRESS*Compression System is designed to increase venous blood flow in at-risk patients in order to help prevent deep vein thrombosis and pulmonary embolism. The System consists of the Controller, the Tubing Sets (provided with the Controller) and single-patient use garments (purchased separately from this Controller). The garments, both leg sleeves and foot cuffs, compress the limbs to enhance venous blood movement. After the compression, the Controller measures the time it takes for the limbs to refill with blood and waits that period of time before the next compression is initiated.
The use of the SCD EXPRESS Compression System with Foot Cuffs is also indicated for: (a) circulation enhancement, (b) edema - acute, (c) edema - chronic, (d) extremity pain incident to trauma or surgery, (e) leg ulcers, and (f) venous stasis /venous insufficiency.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040511 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040511: SCD Express Portable Compression System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040511
Report an extraction error
Are you the manufacturer?
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