# K223228: Dayspring

- Pathway: 510(k) (Traditional)
- Applicant: Koya Medical, Inc.
- Decided: Jan 4, 2024 after 443 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: 10 generations back to K944567 (1995). 21 ancestors in all.
1 later device descends 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)
- K210885: Dayspring, Koya Medical, Inc. (2021) Summary page 4.
- K203178: Flexitouch Plus System, Tactile Systems Technology, Inc. (Dba Tactile Medical) (2020) Summary page 4.

## Most influential descendants
- K253555: Flexitouch® Plus Advanced Pneumatic Compression System (2026), 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 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 ● Reducing wound healing time ● Treatment and assistance in healing stasis dermatitis, venous stasis ulcers, or arterial and diabetic leg ulcers ● Lipedema ● Phlebolymphedema The Dayspring system is developed on a wearable compression technology platform, which is designed to provide mobility for patients.

Source page: https://510kreport.com/device/K223228
Methodology: https://510kreport.com/methodology