510(k) · Cleared
ClearedSCD Garment, Model VP530
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Compression Therapy Concepts, Inc. · JOW Sleeve, Limb, Compressible
Cleared on Sep 25, 2006 after a 75-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it.
- Decided
- Sep 25, 2006
- Review
- 75 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 4 citing it directly.
- This deviceK061967 SCD Garment, Model VP530Compression Therapy Concepts, Inc. · 2006
- Descendant · cites it directly · 1 of its ownK201532 B&J DVT Calf/Thigh Garments, Models 801/830 SeriesB&J Manufacturing, Ltd. · 2020
- Descendant · cites it directly · 1 of its ownK090074 Hygia Health Services Reprocessed Compression Sleeves / Foot CuffsHygia Health Services, Inc. · 2009
- Descendant · 2 generations on · 0 of its ownK253386 DVT GarmentVistar Medical Supplies Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK101702 Midwest Reprocessing Center Reprocessed Venodyne Sleeves/Foot CuffsMidwest Reprocessing Center, LLC · 2010
- Descendant · cites it directly · 0 of its ownK101330 Midwest Reprocessing Center Reprocessed SCD Express Sleeves/ Foot…Midwest Reprocessing Center, LLC · 2010
Most influential descendants
Showing 5 of 5 · See all- K201532B&J DVT Calf/Thigh Garments, Models 801/830 SeriesB&J Manufacturing, Ltd. · 2020 · cites it directly1descendant
- K090074Hygia Health Services Reprocessed Compression Sleeves / Foot CuffsHygia Health Services, Inc. · 2009 · cites it directly1descendant
- K253386DVT GarmentVistar Medical Supplies Co., Ltd. · 2026 · 2 generations on0descendants
- K101702Midwest Reprocessing Center Reprocessed Venodyne Sleeves/Foot CuffsMidwest Reprocessing Center, LLC · 2010 · cites it directly0descendants
- K101330Midwest Reprocessing Center Reprocessed SCD Express Sleeves/ Foot Cuffs, Midwest…Midwest Reprocessing Center, LLC · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K061967 | SCD Garment, Model VP530 | Compression Therapy Concepts, Inc. | 2006 | — |
| +1 | K201532 | B&J DVT Calf/Thigh Garments, Models 801/830 Series | B&J Manufacturing, Ltd. | 2020 | — |
| +1 | K090074 | Hygia Health Services Reprocessed Compression Sleeves / Foot Cuffs | Hygia Health Services, Inc. | 2009 | — |
| +2 | K253386 | DVT Garment | Vistar Medical Supplies Co., Ltd. | 2026 | — |
| +1 | K101702 | Midwest Reprocessing Center Reprocessed Venodyne Sleeves/Foot Cuffs | Midwest Reprocessing Center, LLC | 2010 | — |
| +1 | K101330 | Midwest Reprocessing Center Reprocessed SCD Express Sleeves/ Foot Cuffs… | Midwest Reprocessing Center, LLC | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2020 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (5)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201532 | B&J DVT Calf/Thigh Garments, Models 801/830 Series | 2020 | 1 |
| K090074 | Hygia Health Services Reprocessed Compression Sleeves / Foot Cuffs | 2009 | 1 |
| K101702 | Midwest Reprocessing Center Reprocessed Venodyne Sleeves/Foot Cuffs | 2010 | 0 |
| K101330 | Midwest Reprocessing Center Reprocessed SCD Express Sleeves/ Foot Cuffs, Midwest… | 2010 | 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?
- Of its descendants, K201532 (B&J Manufacturing, Ltd., 2020) has gone furthest, with 1 descendant of its own.
How does its category compare?
All JOW devicesJOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 VasoQuential is designed to increase venous blood flow in at risk patients in order to help prevent Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE).
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K061967 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061967: SCD Garment, Model VP530.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061967
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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