# K254240: Echo-2

- Pathway: 510(k) (Traditional)
- Applicant: Neko Health AB
- Decided: Sep 22, 2026 after 267 days
- Product code: QOK (Hardware And Software For Optical Camera-Based Measurement Of Heart Rate And Respiratory Rate)
- Device class: 2
- Regulation: 21 CFR 870.2786
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN200038 (2021). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN200038: Gili Pro BioSensor (also known as “Gili BioSensor System”), Continuse Biometrics, Ltd. (2021) Summary page 6.

## Indications for use
The Echo-2 device includes an optical module that is intended to capture motion-vibration signals from a illuminated skin surface for assessment of physiological information. Such information, captured during spot-measurement, includes: Heart rate. The Echo-2 device is indicated for use by or under the supervision of healthcare professionals for adult patients in a professional healthcare setting. The Echo-2 device should be used with an individual in a supine position (including with a slightly elevated upper body). The information stored by the system may be reviewed by qualified persons. The Echo-2 device is not intended for continuous monitoring and is only intended for spot-check measurements of heart rate. The Echo-2 device is not intended for use in subjects with arrhythmias.

Source page: https://510kreport.com/device/K254240
Methodology: https://510kreport.com/methodology