510(k) · Cleared
ClearedLympha Press Plus Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mego Afek · JOW Sleeve, Limb, Compressible
Cleared on Nov 30, 2001 as substantially equivalent to K810338 (Mego Afek, 1981) and 1 other predicate after a 56-day review. Its family tree reaches back 1 generation to 1981. 26 later devices descend from it.
- Decided
- Nov 30, 2001
- Review
- 56 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K810338 (1981). 2 ancestors in all. 26 later devices descend from it, 6 citing it directly.
- Root · 1 generation backK810338 Lympha PressMego Afek · 1981
- This deviceK013331 Lympha Press Plus DeviceMego Afek · 2001
- Descendant · cites it directly · 17 of its ownK082149 Lympha Press Optimal, Model# 1201APMego Afek AC, Ltd. · 2008
- Descendant · cites it directly · 14 of its ownK100677 Lympha Press 201MAX, Model 201MAXMego Afek AC, Ltd. · 2010
- Descendant · 2 generations on · 12 of its ownK123647 Circuflow 5208 Sequential Compression DeviceDevon Medical, Inc. · 2013
- Descendant · cites it directly · 6 of its ownK102320 Compressible Limb and Circulation Therapy System Model LX7(V7)Daesung Maref Co., Ltd. · 2011
- Descendant · 2 generations on · 5 of its ownK131420 Petite Basic System 701 EltMego Afek AC, Ltd. · 2013
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- K082149Lympha Press Optimal, Model# 1201APMego Afek AC, Ltd. · 2008 · cites it directly17descendants
- K100677Lympha Press 201MAX, Model 201MAXMego Afek AC, Ltd. · 2010 · cites it directly14descendants
- K123647Circuflow 5208 Sequential Compression DeviceDevon Medical, Inc. · 2013 · 2 generations on12descendants
- K102320Compressible Limb and Circulation Therapy System Model LX7(V7)Daesung Maref Co., Ltd. · 2011 · cites it directly6descendants
- K131420Petite Basic System 701 EltMego Afek AC, Ltd. · 2013 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K810338 | Lympha Press | Mego Afek | 1981 | — |
| 0 (this device) | K013331 | Lympha Press Plus Device | Mego Afek | 2001 | — |
| +1 | K082149 | Lympha Press Optimal, Model# 1201AP | Mego Afek AC, Ltd. | 2008 | — |
| +1 | K100677 | Lympha Press 201MAX, Model 201MAX | Mego Afek AC, Ltd. | 2010 | — |
| +2 | K123647 | Circuflow 5208 Sequential Compression Device | Devon Medical, Inc. | 2013 | — |
| +1 | K102320 | Compressible Limb and Circulation Therapy System Model LX7(V7) | Daesung Maref Co., Ltd. | 2011 | — |
| +2 | K131420 | Petite Basic System 701 Elt | Mego Afek AC, Ltd. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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? (3)
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 |
|---|---|---|---|
| * | K810338 | Lympha PressSummary page 1…vices The Lympha Press Plus device is substantially equivalent to a combination of the Lympha Press device (manufactured by Mego Afek and subject of 510(k) document no. K810338), the Jobst Extremity Pump (manufactured by Jobst, Inc. and subject of 510(k) document no. K882683) and the Sequential Circulator… | 1981 |
| * | K882683 | Jobst Extremity Pump (R) System 7500Summary page 1…s device (manufactured by Mego Afek and subject of 510(k) document no. K810338), the Jobst Extremity Pump (manufactured by Jobst, Inc. and subject of 510(k) document no. K882683) and the Sequential Circulator device (manufactured by Bio Compression Systems, Inc., a Pre-Amendment Device). 980 === Page 2… | 1988 |
| * | — | Sequential Circulator device Named without a submission number |
What descends from it? (26)
See all 266 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082149 | Lympha Press Optimal, Model# 1201AP | 2008 | 17 |
| K100677 | Lympha Press 201MAX, Model 201MAX | 2010 | 14 |
| K102320 | Compressible Limb and Circulation Therapy System Model LX7(V7) | 2011 | 6 |
| K112441 | Compressible Limb and Circulation Therapy System | 2012 | 1 |
| K152228 | Hydroven 12, Hydroven 12 Garments | 2016 | 0 |
| K100521 | Comfysleeve 1-75 and Lymphapod Sleeves, for Use with LP Optimal and Plus | 2010 | 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?
How does its category compare?
All JOW devicesJOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Treatment of Lymphatic Disorders, Venous Disorders, Post-mastectomy Lymphedema and Dysfunction of the “Muscle Pump”.
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/K013331 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013331: Lympha Press Plus Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013331
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026