510(k) · Cleared
ClearedVaso Press DVT System, Models VP500, VP501
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Britt Corp., Inc. · JOW Sleeve, Limb, Compressible
Cleared on Jun 22, 2000 after a 451-day review. The FDA summary names no predicate by number. 13 later devices descend from it.
- Decided
- Jun 22, 2000
- Review
- 451 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 0
13 later devices descend from it, 4 citing it directly.
- This deviceK991038 Vaso Press DVT System, Models VP500, VP501Britt Corp., Inc. · 2000
- Descendant · cites it directly · 8 of its ownK090308 Restep Dvy System, Model RSP-101Stortford Medical, LLC · 2009 · Recalled
- Descendant · cites it directly · 6 of its ownK130571 Devon Cirona 6100 DVTDevon Medical, Inc. · 2013
- Descendant · 2 generations on · 4 of its ownK141578 Devon Cirona 6200 DVTDevon Medical · 2014
- Descendant · cites it directly · 3 of its ownK112838 Vasopress Reprocessed DVT Leg / Foot GarmentsCompression Therapy Concepts, Inc. · 2011
- Descendant · 2 generations on · 1 of its ownK201547 B&J DVT Foot Garments, Models 820 SeriesB&J Manufacturing, Ltd. · 2020
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K090308Restep Dvy System, Model RSP-101Stortford Medical, LLC · 2009 · cites it directly8descendants
- K130571Devon Cirona 6100 DVTDevon Medical, Inc. · 2013 · cites it directly6descendants
- K141578Devon Cirona 6200 DVTDevon Medical · 2014 · 2 generations on4descendants
- K112838Vasopress Reprocessed DVT Leg / Foot GarmentsCompression Therapy Concepts, Inc. · 2011 · cites it directly3descendants
- K201547B&J DVT Foot Garments, Models 820 SeriesB&J Manufacturing, Ltd. · 2020 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K991038 | Vaso Press DVT System, Models VP500, VP501 | Britt Corp., Inc. | 2000 | — |
| +1 | K090308 | Restep Dvy System, Model RSP-101 | Stortford Medical, LLC | 2009 | 1 |
| +1 | K130571 | Devon Cirona 6100 DVT | Devon Medical, Inc. | 2013 | — |
| +2 | K141578 | Devon Cirona 6200 DVT | Devon Medical | 2014 | — |
| +1 | K112838 | Vasopress Reprocessed DVT Leg / Foot Garments | Compression Therapy Concepts, Inc. | 2011 | — |
| +2 | K201547 | B&J DVT Foot Garments, Models 820 Series | B&J Manufacturing, Ltd. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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?
The FDA summary names no predicate by number.
What descends from it? (13)
See all 134 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?
- Of its descendants, K090308 (Stortford Medical, LLC, 2009) has gone furthest, with 8 descendants 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 Vaso Press system is an external pneumatic compression system intended to lower the risk of deep vein thrombosis (DVT) in patients whom may be at risk
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/K991038 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991038: Vaso Press DVT System, Models VP500, VP501.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991038
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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