# K100677: Lympha Press 201MAX, Model 201MAX

- Pathway: 510(k) (Traditional)
- Applicant: Mego Afek AC, Ltd.
- Decided: May 20, 2010 after 71 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: 3 generations back to K810338 (1981). 4 ancestors in all.
14 later devices descend from it; 2 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082149: Lympha Press Optimal, Model# 1201AP, Mego Afek AC, Ltd. (2008) Summary page 1.
- K013331: Lympha Press Plus Device, Mego Afek (2001) Summary page 1.

## Most influential descendants
- K123647: Circuflow 5208 Sequential Compression Device (2013), 12 descendants of its own
- K131420: Petite Basic System 701 Elt (2013), 5 descendants of its own
- K143185: entré Model PD08-U (2015), 4 descendants of its own
- K172770: AIROS 6 Sequential Compression Device (2018), 3 descendants of its own
- K193069: AIROS 6 Sequential Compression Device (2019), 2 descendants of its own

## Indications for use
Primary lymphedema Secondary lymphedema Venous insufficiency Venous stasis ulcers Dysfunction of the muscle pump

Source page: https://510kreport.com/device/K100677
Methodology: https://510kreport.com/methodology