# K082149: Lympha Press Optimal, Model# 1201AP

- Pathway: 510(k) (Traditional)
- Applicant: Mego Afek AC, Ltd.
- Decided: Oct 6, 2008 after 68 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: 2 generations back to K810338 (1981). 3 ancestors in all.
17 later devices descend from it; 3 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013331: Lympha Press Plus Device, Mego Afek (2001) Summary page 2.

## Most influential descendants
- K100677: Lympha Press 201MAX, Model 201MAX (2010), 14 descendants of its own
- 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

## Indications for use
Primary lymphedema (for example, congenital/ milroy's disease) Secondary lymphedema (for example, post-mastectomy, chronic edema, post-traumatic edema) Venous disorders (for example, venous insufficiency, varicose veins, venous stasis ulcers) Dysfunction of the muscle pump (for example, promotion of wound recovery, reduction of edema and lower limb pain following trauma and sports injuries) The device is intended to be used by the patient at home, as well as by physicians at clinics or hospitals.

Source page: https://510kreport.com/device/K082149
Methodology: https://510kreport.com/methodology