FDA 510(k) · Neko Health
K254240: Echo-2 (Neko Health AB)
Neko Health AB received FDA 510(k) K254240 for Echo-2, with a decision date of Sep 22, 2026 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K254240 |
|---|---|
| Pathway | 510(k) |
| Applicant | Neko Health AB |
| Device name | Echo-2 |
| Product code | QOK: Hardware And Software For Optical Camera-Based Measurement Of Heart Rate And Respiratory Rate |
| Regulation (21 CFR) | 870.2786 |
| Device class | Class 2 |
| Date received | Dec 29, 2025 |
| Decision date | Sep 22, 2026 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Traditional |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
? 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.
Extracted automatically from FDA's 510(k) summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
Predicates parsed from FDA documents
FDA numbers found next to the word "predicate" in the summary. The list can include reference devices; check the PDF for which device is the primary predicate.
- DEN200038 Gili Pro BioSensor (also known as Gili… (Continuse)
ChatPPG interpretation
A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.
Product code QOK is "Hardware And Software For Optical Camera-Based Measurement Of Heart Rate And Respiratory Rate", class 2, 21 CFR 870.2786. FDA's definition: "The device uses an optical sensor system and software algorithms to obtain and analyze video signal and estimate pulse rate, heart rate, respiratory rate and/or breathing rates. This device is not intended to independently direct therapy."
Our labels for filtering: claim Heart rate / pulse, sensor Camera (rPPG). These are heuristics, not FDA fields.