510(k) · Cleared
ClearedManaFlow
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 Aug 6, 2020 as substantially equivalent to K131193 (Tactile Systems Technology, Inc., 2013) and 3 other predicates after a 175-day review. Its family tree reaches back 6 generations to 1992. 1 later device descends from it.
- Decided
- Aug 6, 2020
- Review
- 175 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K915638 (1992). 24 ancestors in all, the oldest K882683 (1988). 1 later device descends from it, 1 citing it directly.
- 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 backK160318 PlasmaFlowManamed, Inc. · 2016
- This deviceK200353 ManaFlowManamed, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK240011 Lymphedema CompressionJkh Health Co., Ltd. · 2024
Most influential descendants
Showing 1 of 1 · See all- K240011Lymphedema CompressionJkh Health Co., Ltd. · 2024 · cites it directly0descendants
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 | K160318 | PlasmaFlow | Manamed, Inc. | 2016 | — |
| 0 (this device) | K200353 | ManaFlow | Manamed, Inc. | 2020 | — |
| +1 | K240011 | Lymphedema Compression | Jkh Health Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 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 | 2 | 0 |
| 2006 | 1 | 0 |
| 2010 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2019 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (4)
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 |
|---|---|---|---|
| * | K131193 | Actitouch Act-Adaptive Compression Therapy SystemSummary page 4…Number: 21 CFR 870.5800 Device Class: II Use: Prescription 3. Predicate device Primary Predicate Device: ACTitouchTM Adaptive Compression Therapy system 510(k) Number: K131193 Clearance Date: June 18, 2013 Submitter: Tactile Systems Technology, Inc. Predicate Device: PlasmaFlow 510(k) Number: K160318 Cl… | 2013 |
| * | K160318 | PlasmaFlowSummary page 4…Compression Therapy system 510(k) Number: K131193 Clearance Date: June 18, 2013 Submitter: Tactile Systems Technology, Inc. Predicate Device: PlasmaFlow 510(k) Number: K160318 Clearance Date: April 1, 2016 Submitter: ManaMed, Inc. Predicate Device: medi pneumatic compression system (pcs) – brio (Model 6… | 2016 |
| * | K183631 | medi pneumatic compression system (pcs) – brio (Model 651)Summary page 4…10(k) Number: K160318 Clearance Date: April 1, 2016 Submitter: ManaMed, Inc. Predicate Device: medi pneumatic compression system (pcs) – brio (Model 651) 510(k) Number: K183631 Clearance Date: January 25, 2019 Submitter: Medi USA, LP Predicate Device: SC-3004FC-DL Sequential Circulator 510(k) Number: K14… | 2019 |
| * | K142640 | Model SC-3004-DL Sequential Circulator, Model SC-3004FC-DL Sequenstial Circulator, Model…Summary page 4…) – brio (Model 651) 510(k) Number: K183631 Clearance Date: January 25, 2019 Submitter: Medi USA, LP Predicate Device: SC-3004FC-DL Sequential Circulator 510(k) Number: K142640 Clearance Date: November 6, 2014 Submitter: Bio Compression Systems, Inc. 4. Description of Subject Device The ManaFlow system,… | 2014 |
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 |
|---|---|---|---|
| K240011 | Lymphedema Compression | 2024 | 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 28 years and passes through 6 companies; a new generation was cleared every 4.3 years on median.
- 2 of the 24 ancestors have a recall of any class.
- Of its descendants, K240011 (Jkh Health Co., Ltd., 2024) has gone furthest, with 0 descendants of its own.
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 ManaFlow system, part numbers MFLOWS51 and MFLOWS2, is comprised of a gradient compression sleeve and a portable intermittent pump to provide graduated compression in both sustained and intermittent settings for use in both the hospital and outpatient setting. ManaFlow 51 is pre-set to the default setting of 50 mmHg and cannot be adjusted, whereas the ManaFlow 52 can be adjusted by the physician to a pressure within the specified range. It is…
Read the full statement (127 words)
The ManaFlow system, part numbers MFLOWS51 and MFLOWS2, is comprised of a gradient compression sleeve and a portable intermittent pump to provide graduated compression in both sustained and intermittent settings for use in both the hospital and outpatient setting. ManaFlow 51 is pre-set to the default setting of 50 mmHg and cannot be adjusted, whereas the ManaFlow 52 can be adjusted by the physician to a pressure within the specified range. It is intended for use in:
* Treatment of lymphedema
* Treatment of chronic venous insufficiency
* Treatment and promotion of healing of stasis dermatitis and venous stasis ulcers
* Reducing venous leg ulcer healing time
* Reducing edema due to venous stasis
» Enhancing venous return
The device is intended for home, and hospital use.
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/K200353 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200353: ManaFlow.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200353
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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