510(k) · Cleared
ClearedVesoflow
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Caremed Supply, Inc. · JOW Sleeve, Limb, Compressible
Cleared on Aug 25, 2011 as substantially equivalent to K010744 (Huntleigh Healthcare, Inc., 2002) and 1 other predicate after a 140-day review. Its family tree reaches back 2 generations to 1996. 6 later devices descend from it.
- Decided
- Aug 25, 2011
- Review
- 140 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K953648 (1996). 4 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK953648 A-V Impulse System Model 6060Novamedix, Ltd. · 1996
- 1 generation backK040511 SCD Express Portable Compression SystemTyco Healthcare/Kendall · 2004
- This deviceK110977 VesoflowCaremed Supply, Inc. · 2011
- Descendant · cites it directly · 4 of its ownK141064 Vesoflow Plus DVT Compression DeviceCaremed Supply, Inc. · 2014
- Descendant · 2 generations on · 1 of its ownK200154 B&J DVT Compression Devices MHH800/MHH800SQB&J Manufacturing, Ltd. · 2020
- Descendant · 2 generations on · 0 of its ownK250242 Compression Therapy Device (LGT-2202DVT)Guangzhou Longest Medical Technology Co., Ltd. · 2026
- Descendant · 3 generations on · 0 of its ownK231801 MedHealth DVT compression Devices MHH900S/MHH900EMedhealth Medical Limited · 2023
- Descendant · 2 generations on · 0 of its ownK181217 VesoFlow Lite DVT Compression DeviceCaremed Supply, Inc. · 2018
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K141064Vesoflow Plus DVT Compression DeviceCaremed Supply, Inc. · 2014 · cites it directly4descendants
- K200154B&J DVT Compression Devices MHH800/MHH800SQB&J Manufacturing, Ltd. · 2020 · 2 generations on1descendant
- K250242Compression Therapy Device (LGT-2202DVT)Guangzhou Longest Medical Technology Co., Ltd. · 2026 · 2 generations on0descendants
- K231801MedHealth DVT compression Devices MHH900S/MHH900EMedhealth Medical Limited · 2023 · 3 generations on0descendants
- K181217VesoFlow Lite DVT Compression DeviceCaremed Supply, Inc. · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K953648 | A-V Impulse System Model 6060 | Novamedix, Ltd. | 1996 | — |
| −1 | K040511 | SCD Express Portable Compression System | Tyco Healthcare/Kendall | 2004 | — |
| 0 (this device) | K110977 | Vesoflow | Caremed Supply, Inc. | 2011 | — |
| +1 | K141064 | Vesoflow Plus DVT Compression Device | Caremed Supply, Inc. | 2014 | — |
| +2 | K200154 | B&J DVT Compression Devices MHH800/MHH800SQ | B&J Manufacturing, Ltd. | 2020 | — |
| +2 | K250242 | Compression Therapy Device (LGT-2202DVT) | Guangzhou Longest Medical Technology Co., Ltd. | 2026 | — |
| +3 | K231801 | MedHealth DVT compression Devices MHH900S/MHH900E | Medhealth Medical Limited | 2023 | — |
| +2 | K181217 | VesoFlow Lite DVT Compression Device | Caremed Supply, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 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 |
|---|---|---|---|
| * | K010744 | Flowtron Universal, Model AC600Summary page 2…l Equivalence Products which are substantially equivalent to the Vesoflow are the Tyco/Kendall SCD Express (K(040511) and the Huntleigh Healthcare Flowtron Universal (IC010744). Performance Data The Vesoflow SQS and IPCS compression therapy devices have been tested to and meet IEC 60601-1 Standard for… | 2002 |
| * | K040511 | SCD Express Portable Compression SystemSummary page 1…pression Therapy Device Classification Name Sleeve, Limb, Compression Predicate Devices Huntleigh Healthcare Universal Flowtron (KO 10744) Tyco/ Kendall SCD Express (K04051 1) )t(0-7*7 Indication for Use:… | 2004 |
What descends from it? (6)
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 15 years and passes through 3 companies; a new generation was cleared every 8.4 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K141064 (Caremed Supply, Inc., 2014) has gone furthest, with 4 descendants of its own.
- 6 other devices also cite its predicate K010744.
How does its category compare?
All JOW devicesJOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
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 Caremed Supply Inc. Vesoflow SQS and IPCS Deep Vein Thrombosis (DVT) Compression Devices are intended to increase venous blood flow in at risk patients in order to help prevent deep vein thrombosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110977 · printed Nov 5, 2026
Cite this page
510(k) Report. “K110977: Vesoflow.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K110977
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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