# K253555: Flexitouch® Plus Advanced Pneumatic Compression System

- Pathway: 510(k) (Traditional)
- Applicant: Tactile Medical
- Decided: Jul 31, 2026 after 259 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: 11 generations back to K944567 (1995). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203178: Flexitouch Plus System, Tactile Systems Technology, Inc. (Dba Tactile Medical) (2020) Summary page 5.
- K223228: Dayspring, Koya Medical, Inc. (2024) Summary page 5.

## Indications for use
The Flexitouch Plus system and garments for legs, arms, trunk and chest are intended for use by medical professionals and patients who are under medical supervision to increase lymphatic flow in the treatment of many conditions, such as: ■ Lymphedema ■ Primary lymphedema ■ Post-mastectomy edema ■ Edema following trauma and sports injuries ■ Post-immobilization edema ■ Venous insufficiency ■ Reduction in wound healing time ■ Treatment and assistance in healing stasis dermatitis, venous stasis ulcers, or arterial ulcers and diabetic leg ulcers ■ Lipedema ■ Phlebolymphedema The Flexitouch Plus system and garments for the head and neck are intended for use by medical professionals and patients who are under medical supervision for the treatment of head and neck lymphedema.

Source page: https://510kreport.com/device/K253555
Methodology: https://510kreport.com/methodology