510(k) · Cleared
ClearedLympha Press Optimal Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mego Afek AC, Ltd. · JOW Sleeve, Limb, Compressible
Cleared on Feb 27, 2019 after a 216-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 7 later devices descend from it.
- Decided
- Feb 27, 2019
- Review
- 216 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 2 citing it directly.
- This deviceK182003 Lympha Press Optimal PlusMego Afek AC, Ltd. · 2019
- Descendant · cites it directly · 5 of its ownK203178 Flexitouch Plus SystemTactile Systems Technology, Inc. (Dba Tactile Medical) · 2020
- Descendant · 2 generations on · 4 of its ownK210885 DayspringKoya Medical, Inc. · 2021
- Descendant · 2 generations on · 1 of its ownK223228 DayspringKoya Medical, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK253555 Flexitouch® Plus Advanced Pneumatic Compression SystemTactile Medical · 2026
- Descendant · cites it directly · 0 of its ownK251086 PnueAira (PNCU-01)Biotab, LLC · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K203178Flexitouch Plus SystemTactile Systems Technology, Inc. (Dba Tactile Medical) · 2020 · cites it directly5descendants
- K210885DayspringKoya Medical, Inc. · 2021 · 2 generations on4descendants
- K223228DayspringKoya Medical, Inc. · 2024 · 2 generations on1descendant
- K253555Flexitouch® Plus Advanced Pneumatic Compression SystemTactile Medical · 2026 · 2 generations on0descendants
- K251086PnueAira (PNCU-01)Biotab, LLC · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K182003 | Lympha Press Optimal Plus | Mego Afek AC, Ltd. | 2019 | — |
| +1 | K203178 | Flexitouch Plus System | Tactile Systems Technology, Inc. (Dba Tactile Medical) | 2020 | — |
| +2 | K210885 | Dayspring | Koya Medical, Inc. | 2021 | — |
| +2 | K223228 | Dayspring | Koya Medical, Inc. | 2024 | — |
| +2 | K253555 | Flexitouch® Plus Advanced Pneumatic Compression System | Tactile Medical | 2026 | — |
| +1 | K251086 | PnueAira (PNCU-01) | Biotab, LLC | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (7)
2 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?
- Of its descendants, K203178 (Tactile Systems Technology, Inc. (Dba Tactile Medical), 2020) has gone furthest, with 5 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. 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 device is intended for use by medical professionals, and patients who are under medical supervision, in treating many conditions such as:
• Primary lymphedema
• Secondary lymphedema
• Venous insufficiency
• Venous stasis ulcers
• Dysfunction of the muscle pump
• Post mastectomy edema
• Edema following trauma and sports issues
• Post immobilization edema
• Reducing wound healing time
• Reduction of pain and swelling after injury and surgery
• The device may also be beneficial in the management of Lipoedema
The device is intended for hospital, home, and clinic use.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K182003 · printed Nov 3, 2026
Cite this page
510(k) Report. “K182003: Lympha Press Optimal Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K182003
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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