# K210885: Dayspring

- Pathway: 510(k) (Special)
- Applicant: Koya Medical, Inc.
- Decided: Apr 23, 2021 after 29 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: 9 generations back to K944567 (1995). 20 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193288: Koya Ripple, Koya, Inc. (2020) Summary page 4.
- K203178: Flexitouch Plus System, Tactile Systems Technology, Inc. (Dba Tactile Medical) (2020) Summary page 4.

## Most influential descendants
- 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 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/K210885
Methodology: https://510kreport.com/methodology