FDA De Novo · Continuse
DEN200038: Gili Pro BioSensor (also known as Gili BioSensor System) (Continuse Biometrics , Ltd.)
Continuse Biometrics , Ltd. received FDA De Novo DEN200038 for Gili Pro BioSensor (also known as Gili BioSensor System), with a decision date of Apr 1, 2021.
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | DEN200038 |
|---|---|
| Pathway | De Novo |
| Applicant | Continuse Biometrics , Ltd. |
| Device name | Gili Pro BioSensor (also known as Gili BioSensor System) |
| 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 | Jun 12, 2020 |
| Decision date | Apr 1, 2021 |
| Decision | Unknown (DENG) |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
The Gili Pro BioSensor (Gili BioSensor System) includes an optical module that is intended to capture motion-vibration signals from an illuminated surface for assessment of physiological information. Such information, captured during spot-measurement, includes: Heart rate Respiratory rate The device is indicated for use by or under the supervision of healthcare professionals for adult patients in a hospital, outpatient, or other medical care settings, or for clinical research purposes. The device should be used while the subject is seated upright either in a chair or in a bed. The information stored on the system may be reviewed by qualified persons.
Extracted automatically from FDA's decision 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
A De Novo request is for a new type of device with no legally marketed predicate. When FDA grants it, the device can serve as a predicate for later 510(k) submissions. 1 record in this database cites DEN200038 as a predicate (listed below).
Later records that cite DEN200038
- K254240 Echo-2 (Neko Health, Sep 22, 2026, QOK)
ChatPPG interpretation
A granted De Novo request authorizes a new type of low- to moderate-risk device and creates a classification regulation for it (here 21 CFR 870.2786). The usual wording is "granted" or "authorized", not "approved". 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.