QOKClass II

Hardware And Software For Optical Camera-Based Measurement Of Heart Rate And Respiratory Rate

21 CFR 870.2786 / Cardiovascular

QOK is the FDA product code for Hardware And Software For Optical Camera-Based Measurement Of Heart Rate And Respiratory Rate, a class II device type, regulated under 21 CFR 870.2786. FDA's definition for this code reads: "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". As of 2026-09-10, FDA records hold one 510(k) clearance under this code, the most recent dated 2021-04-01, and no recalls.

Classification record

Product code: QOK
Device name: Hardware And Software For Optical Camera-Based Measurement Of Heart Rate And Respiratory Rate
FDA 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.
Regulation: 21 CFR 870.2786
Device class: Class II
Review panel: Cardiovascular
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 2
Ingested recalls: 0

Clearances, product code QOK

By decision year

2 clearances under product code QOK with a decision year between 2021 and 2026, 2021 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code QOK by decision year
Year	Clearances
2021	1
2026	1

Applicants with the most clearances

Product code QOK

Applicants holding the most 510(k) clearances under product code QOK
Applicant	Clearances
Continuse Biometrics, Ltd.	1
Neko Health AB	1

Companies listing this code with FDA

Companies whose registered establishments list this code

Neko Health AB

Recent clearances

Product code QOK

Recent recalls

Product code QOK

FDA records show no recalls under product code QOK.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)