510(k) · Cleared
ClearedDVT Motion Pneumatic Compression Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Koge Micro Tech Co., Ltd. · JOW Sleeve, Limb, Compressible
Cleared on Mar 6, 2024 as substantially equivalent to K180248 (Bio Compression Systems, Inc., 2018) after a 219-day review. Its family tree reaches back 6 generations to 1992.
- Decided
- Mar 6, 2024
- Review
- 219 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K915638 (1992). 22 ancestors in all, the oldest K881632 (1988). No later device cites it as a predicate yet.
- Root · 6 generations backK915638 Talley TM200 Intermttent Compression UnitProgressive Medical Technology, Inc. · 1992
- 5 generations backK022340 Travelair Portable Compression SystemDynamic Air, Inc. · 2003
- 4 generations backK061125 Dvtcare CA5Doctors Orders · 2006
- 3 generations backK103187 Tripleplay-VT Vascular Therapy SystemWildcat Medical, Inc. · 2011
- 2 generations backK133274 Vena ProInnovamed Health, LLC · 2014
- 1 generation backK180248 VascuEase IC-1200-WHBio Compression Systems, Inc. · 2018
- This deviceK232270 DVT Motion Pneumatic Compression DeviceKoge Micro Tech Co., Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K915638 | Talley TM200 Intermttent Compression Unit | Progressive Medical Technology, Inc. | 1992 | — |
| −5 | K022340 | Travelair Portable Compression System | Dynamic Air, Inc. | 2003 | — |
| −4 | K061125 | Dvtcare CA5 | Doctors Orders | 2006 | — |
| −3 | K103187 | Tripleplay-VT Vascular Therapy System | Wildcat Medical, Inc. | 2011 | — |
| −2 | K133274 | Vena Pro | Innovamed Health, LLC | 2014 | — |
| −1 | K180248 | VascuEase IC-1200-WH | Bio Compression Systems, Inc. | 2018 | — |
| 0 (this device) | K232270 | DVT Motion Pneumatic Compression Device | Koge Micro Tech Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2013 | 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 |
|---|---|---|---|
| * | K180248 | VascuEase IC-1200-WHSummary page 4…Inc. Classification Product Code: JOW Regulation number: 870.5800 Device Class: Ⅱ 510(k) Number: K180248 Koge Micro Te… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
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 32 years and passes through 7 companies; a new generation was cleared every 4.7 years on median.
- 2 of the 22 ancestors have a recall of any class.
How does its category compare?
All JOW devicesJOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 Motion Pneumatic Compression Device is a prescription device intended for prophylaxis of Deep Vein Thrombosis
(DVT), stimulating venous and arterial circulation, aiding in the prevention of venous stasis ulcers, aiding in the healing
of cutaneous ulcers, reducing acute/chronic edema and compartmental pressures. For use in home or hospital setting.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232270 · printed Nov 5, 2026
Cite this page
510(k) Report. “K232270: DVT Motion Pneumatic Compression Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K232270
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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