# K131420: Petite Basic System 701 Elt

- Pathway: 510(k) (Traditional)
- Applicant: Mego Afek AC, Ltd.
- Decided: Nov 1, 2013 after 169 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: 4 generations back to K810338 (1981). 5 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100677: Lympha Press 201MAX, Model 201MAX, Mego Afek AC, Ltd. (2010) Summary page 1.

## Most influential descendants
- K143185: entré Model PD08-U (2015), 4 descendants of its own
- 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
* Primary lymphedlema * Secondary lymphedemna * Venous insufficiency * Venous stasis ulcers * Dysfunction of the 'muscle pump"

Source page: https://510kreport.com/device/K131420
Methodology: https://510kreport.com/methodology