510(k) · Cleared
ClearedB&J MHP800 Deep Vein Thrombosis (DVT) Prevention System
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 10, 2020 as substantially equivalent to K151189 (Devon Medical Products, 2015) after a 128-day review. Its family tree reaches back 6 generations to 1992.
- Decided
- Jul 10, 2020
- Review
- 128 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K915638 (1992). 17 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK915638 Talley TM200 Intermttent Compression UnitProgressive Medical Technology, Inc. · 1992
- 5 generations backK022340 Travelair Portable Compression SystemDynamic Air, Inc. · 2003
- 4 generations backK061125 Dvtcare CA5Doctors Orders · 2006
- 3 generations backK103187 Tripleplay-VT Vascular Therapy SystemWildcat Medical, Inc. · 2011
- 2 generations backK133274 Vena ProInnovamed Health, LLC · 2014
- 1 generation backK151189 Cirona 6300 Disposable Deep Vein Thrombosis (DVT) Prevention SystemDevon Medical Products · 2015
- This deviceK200568 B&J MHP800 Deep Vein Thrombosis (DVT) Prevention SystemB&J Manufacturing, Ltd. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K915638 | Talley TM200 Intermttent Compression Unit | Progressive Medical Technology, Inc. | 1992 | — |
| −5 | K022340 | Travelair Portable Compression System | Dynamic Air, Inc. | 2003 | — |
| −4 | K061125 | Dvtcare CA5 | Doctors Orders | 2006 | — |
| −3 | K103187 | Tripleplay-VT Vascular Therapy System | Wildcat Medical, Inc. | 2011 | — |
| −2 | K133274 | Vena Pro | Innovamed Health, LLC | 2014 | — |
| −1 | K151189 | Cirona 6300 Disposable Deep Vein Thrombosis (DVT) Prevention System | Devon Medical Products | 2015 | — |
| 0 (this device) | K200568 | B&J MHP800 Deep Vein Thrombosis (DVT) Prevention System | B&J Manufacturing, Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 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 |
|---|---|---|---|
| * | K151189 | Cirona 6300 Disposable Deep Vein Thrombosis (DVT) Prevention SystemSummary page 5…p Vein Thrombosis (DVT) 510(k) Summary 4-1 MHP800 DVT Compression Device 510(k) Submission Prevention System has been cleared by FDA through 510(k) No. K151189 (Decision Date - September 18, 2015). The identified reference devices within this submission are as follows: Eezcare Medical C… | 2015 |
| † | K191937 | Ezvena IPC, Ezvena SQS | 2020 |
| † | K141578 | Devon Cirona 6200 DVT | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
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 28 years and passes through 7 companies; a new generation was cleared every 4.7 years on median.
- 2 of the 17 ancestors have a recall of any class.
- 3 other devices also cite its predicate K151189.
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 MHP800 deep vein thrombosis prevention system is intended to be an easy to use portable system, prescribed by a physician, to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions). The device can be used in the home or clinical settings to: Aid in the prevention of DVT; Enhance blood circulation; Diminish post-operative pain and swelling; Reduce wound healing time; Aid in the…
Read the full statement (114 words)
The B&J MHP800 deep vein thrombosis prevention system is intended to be an easy to use portable system, prescribed by a physician, to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions).
The device can be used in the home or clinical settings to:
Aid in the prevention of DVT;
Enhance blood circulation;
Diminish post-operative pain and swelling;
Reduce wound healing time;
Aid in the treatment of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs;
- As a prophylaxis for DVT by persons expecting to be stationary for long periods of time
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/K200568 · printed Nov 3, 2026
Cite this page
510(k) Report. “K200568: B&J MHP800 Deep Vein Thrombosis (DVT) Prevention System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K200568
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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