# K193288: Koya Ripple

- Pathway: 510(k) (Traditional)
- Applicant: Koya, Inc.
- Decided: Jun 16, 2020 after 202 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: 8 generations back to K944567 (1995). 17 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170216: Flexitouch System, Tactile Systems Technology, Inc. (Dba Tactile Medical) (2017) Summary page 4.

## Most influential descendants
- 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
- K222823: AeroDVx Arm System (2023), 0 descendants of its own
- K212287: Dayspring Lite (2021), 0 descendants of its own

## Indications for use
The Koya Dayspring system is a prescription only wearable compression system that is intended for use in a clinic or home setting by medical professionals and patients who are under medical supervision for the treatment of the following: ● Lymphedema ● Primary lymphedema ● Post mastectomy edema ● Edema following trauma and sports injuries ● Post immobilization edema ● Venous insufficiency ● Reducing wound healing time The Koya Dayspring system is developed on a wearable compression technology platform, which is designed to provide mobility for patients.

Source page: https://510kreport.com/device/K193288
Methodology: https://510kreport.com/methodology