510(k) · Cleared
ClearedVascuEase IC-1200-WH
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio Compression Systems, Inc. · JOW Sleeve, Limb, Compressible
Cleared on Aug 7, 2018 as substantially equivalent to K133274 (Innovamed Health, LLC, 2014) and 1 other predicate after a 190-day review. Its family tree reaches back 5 generations to 1992. 1 later device descends from it.
- Decided
- Aug 7, 2018
- Review
- 190 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K915638 (1992). 21 ancestors in all, the oldest K881632 (1988). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK915638 Talley TM200 Intermttent Compression UnitProgressive Medical Technology, Inc. · 1992
- 4 generations backK022340 Travelair Portable Compression SystemDynamic Air, Inc. · 2003
- 3 generations backK061125 Dvtcare CA5Doctors Orders · 2006
- 2 generations backK103187 Tripleplay-VT Vascular Therapy SystemWildcat Medical, Inc. · 2011
- 1 generation backK133274 Vena ProInnovamed Health, LLC · 2014
- This deviceK180248 VascuEase IC-1200-WHBio Compression Systems, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK232270 DVT Motion Pneumatic Compression DeviceKoge Micro Tech Co., Ltd. · 2024
Most influential descendants
Showing 1 of 1 · See all- K232270DVT Motion Pneumatic Compression DeviceKoge Micro Tech Co., Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K915638 | Talley TM200 Intermttent Compression Unit | Progressive Medical Technology, Inc. | 1992 | — |
| −4 | K022340 | Travelair Portable Compression System | Dynamic Air, Inc. | 2003 | — |
| −3 | K061125 | Dvtcare CA5 | Doctors Orders | 2006 | — |
| −2 | K103187 | Tripleplay-VT Vascular Therapy System | Wildcat Medical, Inc. | 2011 | — |
| −1 | K133274 | Vena Pro | Innovamed Health, LLC | 2014 | — |
| 0 (this device) | K180248 | VascuEase IC-1200-WH | Bio Compression Systems, Inc. | 2018 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 |
|---|---|---|---|
| * | K133274 | Vena ProSummary page 4…sible Limb Sleeve Devices are classified as Class II devices, and reviewed by the Division of Cardiovascular Devices. PREDICATE DEVICE Vena Pro Vascular Therapy System, K133274 The secondary predicate device is the Bio Compression Systems IC-1545-DL Multi Flow, K131306 DEVICE DESCRIPTION The VascuEase IC… | 2014 |
| * | K131306 | IC-1545-DL Multi Flo DVT Combo Intermittent Pneumatic Compression DeviceSummary page 4…Cardiovascular Devices. PREDICATE DEVICE Vena Pro Vascular Therapy System, K133274 The secondary predicate device is the Bio Compression Systems IC-1545-DL Multi Flow, K131306 DEVICE DESCRIPTION The VascuEase IC-1200-WH is a portable, rechargeable battery-powered, prescription device intended for home o… | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232270 | DVT Motion Pneumatic Compression Device | 2024 | 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?
- The line of descent spans 26 years and passes through 6 companies; a new generation was cleared every 4.5 years on median.
- 2 of the 21 ancestors have a recall of any class.
- Of its descendants, K232270 (Koge Micro Tech Co., Ltd., 2024) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K133274.
How does its category compare?
All JOW devicesJOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
VascuEase is a prescription device intended for the prophylaxis of Deep Vein Thrombosis (DVT), stimulating venous and arterial circulation, aiding in 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K180248 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180248: VascuEase IC-1200-WH.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180248
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