510(k) · Cleared
ClearedVasopress Reprocessed DVT Leg / Foot Garments
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 Nov 10, 2011 as substantially equivalent to K991038 (Britt Corp., Inc., 2000) and 1 other predicate after a 43-day review. Its family tree reaches back 1 generation to 2000. 3 later devices descend from it.
- Decided
- Nov 10, 2011
- Review
- 43 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K991038 (2000). 2 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK991038 Vaso Press DVT System, Models VP500, VP501Britt Corp., Inc. · 2000
- This deviceK112838 Vasopress Reprocessed DVT Leg / Foot GarmentsCompression Therapy Concepts, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK201547 B&J DVT Foot Garments, Models 820 SeriesB&J Manufacturing, Ltd. · 2020
- Descendant · 2 generations on · 0 of its ownK253386 DVT GarmentVistar Medical Supplies Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK122179 Vasopress DVT Leg Garments (Sterile) Vasopress DVT Foot Garments…Compression Therapy Concepts · 2012
Most influential descendants
Showing 3 of 3 · See all- K201547B&J DVT Foot Garments, Models 820 SeriesB&J Manufacturing, Ltd. · 2020 · cites it directly1descendant
- K253386DVT GarmentVistar Medical Supplies Co., Ltd. · 2026 · 2 generations on0descendants
- K122179Vasopress DVT Leg Garments (Sterile) Vasopress DVT Foot Garments (Sterile)Compression Therapy Concepts · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K991038 | Vaso Press DVT System, Models VP500, VP501 | Britt Corp., Inc. | 2000 | — |
| 0 (this device) | K112838 | Vasopress Reprocessed DVT Leg / Foot Garments | Compression Therapy Concepts, Inc. | 2011 | — |
| +1 | K201547 | B&J DVT Foot Garments, Models 820 Series | B&J Manufacturing, Ltd. | 2020 | — |
| +2 | K253386 | DVT Garment | Vistar Medical Supplies Co., Ltd. | 2026 | — |
| +1 | K122179 | Vasopress DVT Leg Garments (Sterile) Vasopress DVT Foot Garments (Sterile) | Compression Therapy Concepts | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2020 | 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? (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 |
|---|---|---|---|
| * | K991038 | Vaso Press DVT System, Models VP500, VP501Summary page 1…devices in commercial distribution by Compression Therapy Concepts, Inc., 35 James Way, Eatontown, NJ 07724. Specifically the VasoPress DVT Leg Garments VP 501 (K991038) and VasoPress DVT Foot Garments VP 520 (K003828). Device Description: The VasoPress Reprocessed DVT Leg Garment consis… | 2000 |
| * | K003828 | Vaso Press DVT Foot Garment #VP 520Summary page 1…Therapy Concepts, Inc., 35 James Way, Eatontown, NJ 07724. Specifically the VasoPress DVT Leg Garments VP 501 (K991038) and VasoPress DVT Foot Garments VP 520 (K003828). Device Description: The VasoPress Reprocessed DVT Leg Garment consists of a brushed nylon outer material bonded to a… | 2001 |
What descends from it? (3)
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?
How does its category compare?
All JOW devicesJOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
The DVT Garment is an external pneumatic compression device intended to lower the risk of deep vein thrombosis (DVT) and resulting pulmonary embolism (PE) in patients who may be at risk for thrombosis formation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112838 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112838: Vasopress Reprocessed DVT Leg / Foot Garments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112838
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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