510(k) · Cleared
ClearedPlasmaFlow
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Manamed, Inc. · JOW Sleeve, Limb, Compressible
Cleared on Apr 1, 2016 as substantially equivalent to K133274 (Innovamed Health, LLC, 2014) after a 56-day review. Its family tree reaches back 5 generations to 1992. 4 later devices descend from it.
- Decided
- Apr 1, 2016
- Review
- 56 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K915638 (1992). 16 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK915638 Talley TM200 Intermttent Compression UnitProgressive Medical Technology, Inc. · 1992
- 4 generations backK022340 Travelair Portable Compression SystemDynamic Air, Inc. · 2003
- 3 generations backK061125 Dvtcare CA5Doctors Orders · 2006
- 2 generations backK103187 Tripleplay-VT Vascular Therapy SystemWildcat Medical, Inc. · 2011
- 1 generation backK133274 Vena ProInnovamed Health, LLC · 2014
- This deviceK160318 PlasmaFlowManamed, Inc. · 2016
- Descendant · cites it directly · 1 of its ownK200353 ManaFlowManamed, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK240011 Lymphedema CompressionJkh Health Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK211235 CIRCUL8 Luxe DVT Prevention DeviceOrtho8, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK211253 PlasmaWaveManamed, Inc. · 2021
Most influential descendants
Showing 4 of 4 · See all- K200353ManaFlowManamed, Inc. · 2020 · cites it directly1descendant
- K240011Lymphedema CompressionJkh Health Co., Ltd. · 2024 · 2 generations on0descendants
- K211235CIRCUL8 Luxe DVT Prevention DeviceOrtho8, Inc. · 2021 · cites it directly0descendants
- K211253PlasmaWaveManamed, Inc. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K915638 | Talley TM200 Intermttent Compression Unit | Progressive Medical Technology, Inc. | 1992 | — |
| −4 | K022340 | Travelair Portable Compression System | Dynamic Air, Inc. | 2003 | — |
| −3 | K061125 | Dvtcare CA5 | Doctors Orders | 2006 | — |
| −2 | K103187 | Tripleplay-VT Vascular Therapy System | Wildcat Medical, Inc. | 2011 | — |
| −1 | K133274 | Vena Pro | Innovamed Health, LLC | 2014 | — |
| 0 (this device) | K160318 | PlasmaFlow | Manamed, Inc. | 2016 | — |
| +1 | K200353 | ManaFlow | Manamed, Inc. | 2020 | — |
| +2 | K240011 | Lymphedema Compression | Jkh Health Co., Ltd. | 2024 | — |
| +1 | K211235 | CIRCUL8 Luxe DVT Prevention Device | Ortho8, Inc. | 2021 | — |
| +1 | K211253 | PlasmaWave | Manamed, Inc. | 2021 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2024 | 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.
What descends from it? (4)
3 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?
- The line of descent spans 24 years and passes through 6 companies; a new generation was cleared every 3.3 years on median.
- 2 of the 16 ancestors have a recall of any class.
- Of its descendants, K200353 (Manamed, Inc., 2020) has gone furthest, with 1 descendant of its own.
- 6 other devices also cite its predicate K133274.
How does its category compare?
All JOW devicesJOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 PlasmaFlow, model PF0001, is intended to be an easy to use portable system, prescribed by a physician, for use in the home or clinical setting to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions). This device can be used to: • Aid in the prevention of DVT; • Enhance blood circulation; • Diminish post-operative pain and swelling; • Reduce wound healing time; • Aid in the treatment…
Read the full statement (127 words)
The PlasmaFlow, model PF0001, is intended to be an easy to use portable system, prescribed by a physician, for use in the home or clinical setting to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions). This device can be used to:
• Aid in the prevention of DVT;
• Enhance blood circulation;
• Diminish post-operative pain and swelling;
• Reduce wound healing time;
• Aid in the treatment and healing of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs.
The unit can also be used as an aid in the prophylaxis for DVT by persons expecting to be stationary for long periods of time.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160318 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160318: PlasmaFlow.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160318
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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