# K212287: Dayspring Lite

- Pathway: 510(k) (Special)
- Applicant: Koya Medical, Inc.
- Decided: Sep 21, 2021 after 62 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). 34 ancestors in all.
No later device cites it as a predicate yet.
0 of 35 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.
- K143185: entré Model PD08-U, Tactile Systems Technology, Inc. (2015) Summary page 4.

## Indications for use
Dayspring Lite 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 conditions: • Chronic edema • Lymphedema • Venous insufficiency • Wound healing Dayspring Lite is developed on a wearable compression technology platform, which is designed to provide mobility for patients.

Source page: https://510kreport.com/device/K212287
Methodology: https://510kreport.com/methodology