510(k) · Cleared
ClearedB&J DVT Compression Devices MHH800/MHH800SQ
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 Jul 8, 2020 as substantially equivalent to K141064 (Caremed Supply, Inc., 2014) after a 168-day review. Its family tree reaches back 4 generations to 1996. 1 later device descends from it.
- Decided
- Jul 8, 2020
- Review
- 168 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K953648 (1996). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK953648 A-V Impulse System Model 6060Novamedix, Ltd. · 1996
- 3 generations backK040511 SCD Express Portable Compression SystemTyco Healthcare/Kendall · 2004
- 2 generations backK110977 VesoflowCaremed Supply, Inc. · 2011
- 1 generation backK141064 Vesoflow Plus DVT Compression DeviceCaremed Supply, Inc. · 2014
- This deviceK200154 B&J DVT Compression Devices MHH800/MHH800SQB&J Manufacturing, Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK231801 MedHealth DVT compression Devices MHH900S/MHH900EMedhealth Medical Limited · 2023
Most influential descendants
Showing 1 of 1 · See all- K231801MedHealth DVT compression Devices MHH900S/MHH900EMedhealth Medical Limited · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K953648 | A-V Impulse System Model 6060 | Novamedix, Ltd. | 1996 | — |
| −3 | K040511 | SCD Express Portable Compression System | Tyco Healthcare/Kendall | 2004 | — |
| −2 | K110977 | Vesoflow | Caremed Supply, Inc. | 2011 | — |
| −1 | K141064 | Vesoflow Plus DVT Compression Device | Caremed Supply, Inc. | 2014 | — |
| 0 (this device) | K200154 | B&J DVT Compression Devices MHH800/MHH800SQ | B&J Manufacturing, Ltd. | 2020 | — |
| +1 | K231801 | MedHealth DVT compression Devices MHH900S/MHH900E | Medhealth Medical Limited | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 |
|---|---|---|---|
| * | K141064 | Vesoflow Plus DVT Compression DeviceSummary page 4…ified predicates within this submission are as follows: Caremed Supply, Inc., VESOFLOW PLUS DVT Compression Devices, IPCS/SQS have been cleared by FDA through 510(k) No. K141064 (Decision Date - December 4, 2014). 510(k) Summary 3-6 MHH800/MHH800SQ DVT Compression Devices 510(k) Submissio… | 2014 |
| † | 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 |
|---|---|---|---|
| K231801 | MedHealth DVT compression Devices MHH900S/MHH900E | 2023 | 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 24 years and passes through 4 companies; a new generation was cleared every 7.2 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K231801 (Medhealth Medical Limited, 2023) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K141064.
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 Manufacturing Ltd. MHH800 and MHH800SQ Deep Vein Thrombosis (DVT) Compression Devices are intended to increase venous blood flow in at risk patients in order to help prevent deep vein thrombosis.
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/K200154 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200154: B&J DVT Compression Devices MHH800/MHH800SQ.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200154
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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