510(k) · Cleared
ClearedB&J DVT Foot Garments, Models 820 Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
B&J Manufacturing, Ltd. · JOW Sleeve, Limb, Compressible
Cleared on Sep 18, 2020 as substantially equivalent to K112838 (Compression Therapy Concepts, Inc., 2011) after a 101-day review. Its family tree reaches back 2 generations to 2000. 1 later device descends from it.
- Decided
- Sep 18, 2020
- Review
- 101 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K991038 (2000). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK991038 Vaso Press DVT System, Models VP500, VP501Britt Corp., Inc. · 2000
- 1 generation backK112838 Vasopress Reprocessed DVT Leg / Foot GarmentsCompression Therapy Concepts, Inc. · 2011
- This deviceK201547 B&J DVT Foot Garments, Models 820 SeriesB&J Manufacturing, Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK253386 DVT GarmentVistar Medical Supplies Co., Ltd. · 2026
Most influential descendants
Showing 1 of 1 · See all- K253386DVT GarmentVistar Medical Supplies Co., Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K991038 | Vaso Press DVT System, Models VP500, VP501 | Britt Corp., Inc. | 2000 | — |
| −1 | K112838 | Vasopress Reprocessed DVT Leg / Foot Garments | Compression Therapy Concepts, Inc. | 2011 | — |
| 0 (this device) | K201547 | B&J DVT Foot Garments, Models 820 Series | B&J Manufacturing, Ltd. | 2020 | — |
| +1 | K253386 | DVT Garment | Vistar Medical Supplies Co., Ltd. | 2026 | — |
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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K112838 | Vasopress Reprocessed DVT Leg / Foot GarmentsSummary page 5…this submission is as follows: The B&J DVT Foot Garments, Models 820 Series are substantially equivalent to devices, Foot Garment of VasoPress Reprocessed DVT Garment (K112838 decided on 11/10/2011) in commercial distribution by Compression Therapy Concepts, Inc. 35 James Way Eatontown, NJ 07724-2272. T… | 2011 |
| † | K061814 | Vasopress DVT System, Model VP500D | 2006 |
| † | K181217 | VesoFlow Lite DVT Compression Device | 2018 |
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 |
|---|---|---|---|
| K253386 | DVT Garment | 2026 | 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 20 years and passes through 3 companies; a new generation was cleared every 11.4 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K253386 (Vistar Medical Supplies Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K112838.
How does its category compare?
All JOW devicesJOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 B&J DVT Foot Garments, Models 820 Series are external pneumatic compression devices 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K201547 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201547: B&J DVT Foot Garments, Models 820 Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201547
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