510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN200038Unknown

Gili Pro BioSensor (also known as “Gili BioSensor System”)

Continuse Biometrics, Ltd., Tel-Aviv, IL / Direct, Unknown
FDA source (opens on fda.gov)

DEN200038 is the FDA 510(k) clearance record for Gili Pro BioSensor (also known as “Gili BioSensor System”), a class II device, cleared for Continuse Biometrics , Ltd. on under FDA product code QOK (Hardware And Software For Optical Camera-Based Measurement Of Heart Rate And Respiratory Rate). FDA's definition for product code QOK 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". FDA records list one 510(k) clearance for Continuse Biometrics , Ltd. As of , FDA records show no recalls naming DEN200038.

Clearance record

Decision date
Received
(293 days to decision)
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 II
Review panel
Cardiovascular
Applicant
Continuse Biometrics , Ltd. Habarzel 32b, Tel-Aviv, IL
Third party review
No

Clearances, product code QOK

Trailing 12 months
1 clearance under product code QOK in the twelve months to October 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code QOK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260