# K143185: entré Model PD08-U

- Pathway: 510(k) (Traditional)
- Applicant: Tactile Systems Technology, Inc.
- Decided: May 7, 2015 after 183 days
- Product code: JOW (Sleeve, Limb, Compressible)
- Device class: 2
- Regulation: 21 CFR 870.5800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K810338 (1981). 13 ancestors in all.
4 later devices descend from it; 4 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131420: Petite Basic System 701 Elt, Mego Afek AC, Ltd. (2013) Summary page 4.
- K123959: Circuflow 5150, Devon Medical, Inc. (2013) Summary page 4.
- K123647: Circuflow 5208 Sequential Compression Device, Devon Medical, Inc. (2013) Summary page 4.

## Most influential descendants
- K254217: Aerloom (2026), 0 descendants of its own
- K234155: Nimbl (model PD08-N1) (2024), 0 descendants of its own
- K212287: Dayspring Lite (2021), 0 descendants of its own
- K200564: Aria System (2020), 0 descendants of its own

## Indications for use
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

Source page: https://510kreport.com/device/K143185
Methodology: https://510kreport.com/methodology