510(k) · Cleared
Clearedentré Model PD08-U
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tactile Systems Technology, Inc. · JOW Sleeve, Limb, Compressible
Cleared on May 7, 2015 as substantially equivalent to K131420 (Mego Afek AC, Ltd., 2013) and 2 other predicates after a 183-day review. Its family tree reaches back 5 generations to 1981. 4 later devices descend from it.
- Decided
- May 7, 2015
- Review
- 183 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K810338 (1981). 13 ancestors in all. 4 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK810338 Lympha PressMego Afek · 1981
- 4 generations backK013331 Lympha Press Plus DeviceMego Afek · 2001
- 3 generations backK082149 Lympha Press Optimal, Model# 1201APMego Afek AC, Ltd. · 2008
- 2 generations backK100677 Lympha Press 201MAX, Model 201MAXMego Afek AC, Ltd. · 2010
- 1 generation backK123647 Circuflow 5208 Sequential Compression DeviceDevon Medical, Inc. · 2013
- This deviceK143185 entré Model PD08-UTactile Systems Technology, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK254217 AerloomEvolym, LLC · 2026
- Descendant · cites it directly · 0 of its ownK234155 Nimbl (model PD08-N1)Tactile Medical · 2024
- Descendant · cites it directly · 0 of its ownK212287 Dayspring LiteKoya Medical, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK200564 Aria SystemInova Labs · 2020
Most influential descendants
Showing 4 of 4 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K810338 | Lympha Press | Mego Afek | 1981 | — |
| −4 | K013331 | Lympha Press Plus Device | Mego Afek | 2001 | — |
| −3 | K082149 | Lympha Press Optimal, Model# 1201AP | Mego Afek AC, Ltd. | 2008 | — |
| −2 | K100677 | Lympha Press 201MAX, Model 201MAX | Mego Afek AC, Ltd. | 2010 | — |
| −1 | K123647 | Circuflow 5208 Sequential Compression Device | Devon Medical, Inc. | 2013 | — |
| 0 (this device) | K143185 | entré Model PD08-U | Tactile Systems Technology, Inc. | 2015 | — |
| +1 | K254217 | Aerloom | Evolym, LLC | 2026 | — |
| +1 | K234155 | Nimbl (model PD08-N1) | Tactile Medical | 2024 | — |
| +1 | K212287 | Dayspring Lite | Koya Medical, Inc. | 2021 | — |
| +1 | K200564 | Aria System | Inova Labs | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 2 | 0 |
| 2010 | 2 | 0 |
| 2013 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 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 |
|---|---|---|---|
| * | K131420 | Petite Basic System 701 EltSummary page 4…Name of Device: entré Model PD08-U Classification: Compressible Limb Sleeve (21 CFR 870.5800) Predicate Devices: Petite Basic System 701 ELT (K131420) CircuFlow 5150 (K123959) CircuFlow 5208 (K123647) Device Description… | 2013 |
| * | K123959 | Circuflow 5150Summary page 4…sification: Compressible Limb Sleeve (21 CFR 870.5800) Predicate Devices: Petite Basic System 701 ELT (K131420) CircuFlow 5150 (K123959) CircuFlow 5208 (K123647) Device Description The entré model PD08-U system consists of two… | 2013 |
| * | K123647 | Circuflow 5208 Sequential Compression DeviceSummary page 4…70.5800) Predicate Devices: Petite Basic System 701 ELT (K131420) CircuFlow 5150 (K123959) CircuFlow 5208 (K123647) Device Description The entré model PD08-U system consists of two main components: A controller and a garment. Th… | 2013 |
What descends from it? (4)
4 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 34 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- None of the 13 ancestors has a recall.
- Of its descendants, K254217 (Evolym, LLC, 2026) 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. 2015, 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 entré System is intended for use by medical professionals and patients who are under medical supervision, for the treatment of the following conditions:
• Chronic edema
• Lymphedema
• Venous insufficiency
• Wound healing
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143185 · printed Nov 4, 2026
Cite this page
510(k) Report. “K143185: entré Model PD08-U.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K143185
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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