# DEN200038: Gili Pro BioSensor (also known as “Gili BioSensor System”)

- Pathway: De Novo (Direct)
- Applicant: Continuse Biometrics, Ltd.
- Decided: Apr 1, 2021 after 293 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K254240: Echo-2 (2026), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/DEN200038
Methodology: https://510kreport.com/methodology