510(k) · Cleared
ClearedThe Venous Assist System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Daesung Maref Co., Ltd. · JOW Sleeve, Limb, Compressible
Cleared on Jan 13, 2012 as substantially equivalent to K040511 (Tyco Healthcare/Kendall, 2004) after a 121-day review. Its family tree reaches back 2 generations to 1996. 10 later devices descend from it.
- Decided
- Jan 13, 2012
- Review
- 121 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K953648 (1996). 3 ancestors in all. 10 later devices descend from it, 5 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 deviceK112677 The Venous Assist SystemDaesung Maref Co., Ltd. · 2012
- Descendant · cites it directly · 2 of its ownK123830 Intermittent Pneumatic Compression DeviceDalian Labtek Science & Development Co., Ltd. · 2013
- Descendant · cites it directly · 1 of its ownK203016 DVT-2600Daesung Maref Co., Ltd. · 2020
- Descendant · cites it directly · 1 of its ownK160180 Intermittent Pneumatic Compression systemDaesung Maref Co., Ltd. · 2016
- Descendant · cites it directly · 1 of its ownK150980 Venous Assist SystemDaesung Maref Co., Ltd. · 2016
- Descendant · 2 generations on · 0 of its ownK213313 Veinoflow SCD (Model: LBTK-M-I 5006)Dalian Labtek Science & Development Co., Ltd. · 2022
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K123830Intermittent Pneumatic Compression DeviceDalian Labtek Science & Development Co., Ltd. · 2013 · cites it directly2descendants
- K203016DVT-2600Daesung Maref Co., Ltd. · 2020 · cites it directly1descendant
- K160180Intermittent Pneumatic Compression systemDaesung Maref Co., Ltd. · 2016 · cites it directly1descendant
- K150980Venous Assist SystemDaesung Maref Co., Ltd. · 2016 · cites it directly1descendant
- K213313Veinoflow SCD (Model: LBTK-M-I 5006)Dalian Labtek Science & Development Co., Ltd. · 2022 · 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) | K112677 | The Venous Assist System | Daesung Maref Co., Ltd. | 2012 | — |
| +1 | K123830 | Intermittent Pneumatic Compression Device | Dalian Labtek Science & Development Co., Ltd. | 2013 | — |
| +1 | K203016 | DVT-2600 | Daesung Maref Co., Ltd. | 2020 | — |
| +1 | K160180 | Intermittent Pneumatic Compression system | Daesung Maref Co., Ltd. | 2016 | — |
| +1 | K150980 | Venous Assist System | Daesung Maref Co., Ltd. | 2016 | — |
| +2 | K213313 | Veinoflow SCD (Model: LBTK-M-I 5006) | Dalian Labtek Science & Development Co., Ltd. | 2022 | — |
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 |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 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? (1)
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 |
|---|---|---|---|
| * | K040511 | SCD Express Portable Compression SystemSummary page 2…0[2-077 p~z2cNL G. Substantial Equivalence Information Predicate Device 1 - 51 0(k) number: K04051 1 - Name: SCOD Express"4 system - Classification: 2 1. Comparison with predicate The Venous Assist Syst… | 2004 |
What descends from it? (10)
5 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 16 years and passes through 3 companies; a new generation was cleared every 8.4 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K123830 (Dalian Labtek Science & Development Co., Ltd., 2013) has gone furthest, with 2 descendants of its own.
- 8 other devices also cite its predicate K040511.
How does its category compare?
All JOW devicesJOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
DVT-2600 is a system to prevent DVT (Deep Vein Thrombosis) by improving the blood velocity of patients. DVT-2600 is Circulation Enhancement, Deep Vein Thrombosis Prophylaxis, Edema -Acute, Edema - Chronic, Extremity Pain Incident to Trauma or Surgery, Leg Ulcers, Venous Stasis / Venous Insufficiency.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112677 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112677: The Venous Assist System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112677
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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