510(k) · Cleared
ClearedPlexus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alleva Medical (D.G), Ltd. · JOW Sleeve, Limb, Compressible
Cleared on Aug 27, 2019 as substantially equivalent to K151189 (Devon Medical Products, 2015) after a 123-day review. Its family tree reaches back 6 generations to 1992.
- Decided
- Aug 27, 2019
- Review
- 123 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 deviceK191107 PlexusAlleva Medical (D.G), Ltd. · 2019
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) | K191107 | Plexus | Alleva Medical (D.G), Ltd. | 2019 | — |
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 4…lassification: Compressible Lim Sleeve, 21 CFR 870.5800 Product Code: JOW Device Class: II Predicate Device: Cirona 6300 DVT Prevention Device, Devon Medical Products, K151189 Device Description The Plexus RP100 Portable Deep Vein Thrombosis (“DVT”) Prevention Device is an electronic device that helps… | 2015 |
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 27 years and passes through 7 companies; a new generation was cleared every 3.9 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. 2019, 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 Plexus RP00 Disposable Portable Deep Vein Thrombosis (DVT) Prevention Device is intended to be used in either home or clinical settings for:
• Aiding the prevention of DVT onset
• Enhancing blood circulation in the lower extremities
• Diminishing post-operative pain and swelling
• Reducing wound healing time, and
• Serving as a prophylaxis for DVT for stationary or bedridden individuals
• 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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191107 · printed Nov 5, 2026
Cite this page
510(k) Report. “K191107: Plexus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K191107
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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