# K182003: Lympha Press Optimal Plus

- Pathway: 510(k) (Traditional)
- Applicant: Mego Afek AC, Ltd.
- Decided: Feb 27, 2019 after 216 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
No predicates in its family tree.
7 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K203178: Flexitouch Plus System (2020), 5 descendants of its own
- K210885: Dayspring (2021), 4 descendants of its own
- K223228: Dayspring (2024), 1 descendant of its own
- K253555: Flexitouch® Plus Advanced Pneumatic Compression System (2026), 0 descendants of its own
- K251086: PnueAira (PNCU-01) (2025), 0 descendants of its own

## Indications for use
The device is intended for use by medical professionals, and patients who are under medical supervision, in treating many conditions such as: • Primary lymphedema • Secondary lymphedema • Venous insufficiency • Venous stasis ulcers • Dysfunction of the muscle pump • Post mastectomy edema • Edema following trauma and sports issues • Post immobilization edema • Reducing wound healing time • Reduction of pain and swelling after injury and surgery • The device may also be beneficial in the management of Lipoedema The device is intended for hospital, home, and clinic use.

Source page: https://510kreport.com/device/K182003
Methodology: https://510kreport.com/methodology