510(k) · Cleared
ClearedIntermittent Pneumatic Compression Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dalian Labtek Science & Development Co., Ltd. · JOW Sleeve, Limb, Compressible
Cleared on Aug 16, 2013 as substantially equivalent to K112677 (Daesung Maref Co., Ltd., 2012) after a 247-day review. Its family tree reaches back 3 generations to 1996. 2 later devices descend from it.
- Decided
- Aug 16, 2013
- Review
- 247 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K953648 (1996). 4 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK953648 A-V Impulse System Model 6060Novamedix, Ltd. · 1996
- 2 generations backK040511 SCD Express Portable Compression SystemTyco Healthcare/Kendall · 2004
- 1 generation backK112677 The Venous Assist SystemDaesung Maref Co., Ltd. · 2012
- This deviceK123830 Intermittent Pneumatic Compression DeviceDalian Labtek Science & Development Co., Ltd. · 2013
- Descendant · cites it directly · 0 of its ownK213313 Veinoflow SCD (Model: LBTK-M-I 5006)Dalian Labtek Science & Development Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK141390 Intermittent Pneumatic Compression DeviceWuhan Landing Medical Hi-Tech, Ltd. · 2014
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K953648 | A-V Impulse System Model 6060 | Novamedix, Ltd. | 1996 | — |
| −2 | K040511 | SCD Express Portable Compression System | Tyco Healthcare/Kendall | 2004 | — |
| −1 | K112677 | The Venous Assist System | Daesung Maref Co., Ltd. | 2012 | — |
| 0 (this device) | K123830 | Intermittent Pneumatic Compression Device | Dalian Labtek Science & Development Co., Ltd. | 2013 | — |
| +1 | K213313 | Veinoflow SCD (Model: LBTK-M-I 5006) | Dalian Labtek Science & Development Co., Ltd. | 2022 | — |
| +1 | K141390 | Intermittent Pneumatic Compression Device | Wuhan Landing Medical Hi-Tech, Ltd. | 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 |
|---|---|---|
| 2014 | 1 | 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 |
|---|---|---|---|
| * | K112677 | The Venous Assist SystemSummary page 3…alian Labtek Science & Development Co., Ltd. 2:2:2:2, No.4 Zhengren Strect, Shahekou District, Datian, China 11602) New Device Predicate Device 510(k} Number: K 123830 K112677 Product Code: Jow jow Proprietary Name: Veinoflow SCD, LBTK-M-1 5001 The Venous Assist System DVT-2600 Manufacturer: Dalian… | 2012 |
What descends from it? (2)
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 17 years and passes through 4 companies; a new generation was cleared every 7.5 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K213313 (Dalian Labtek Science & Development Co., Ltd., 2022) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K112677.
How does its category compare?
All JOW devicesJOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
Veinoflow SCD system, Model LBTK-M-l 5001 is a system to prevent DVT (Deep Vein Thrombosis) by improving the blood velocity of patients. LBTK-M-l 5001 is indicated for 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K123830 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123830: Intermittent Pneumatic Compression Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123830
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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