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

DEN200038

ContinUse Biometrics Ltd. · granted 2021-04-01 · product code QOK · Cardiovascular

FDA De Novo summary for Gili Pro BioSensor (also known as “Gili BioSensor System”) (DEN200038)

Constat organizes this clearance into predicate context, validation evidence, reported performance, postmarket signals, and reimbursement links. Each extracted claim stays tied to the public FDA source; missing fields remain explicitly unstated.

Validation studies
2
Cited predicates
0
Performance observations
0
Product code
QOK
FDA De Novo source PDF ↗

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.1)
“Hardware and software for optical camera-based measurement of pulse rate, heart rate, breathing rate, and/or respiratory rate. 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.”
Algorithmsoftware algorithm measures heart and respiratory rate based on analysis of reflected light patterns from motion-vibration signals
source quote (p.2)
“Analysis of these patterns through the software application correlate with heart and respiratory rates, as part of vital signs assessment. The sponsor provided details on how the software algorithm measures heart and respiratory rate.”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedYes
source quote (p.4)
“Appropriate documentation was provided in accordance with FDA's 2014 guidance document titled “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices” to support adequate cybersecurity measures have been taken and will be monitored and updated throughout the device life cycle.”

Validation studies (2)

Bench

sample size not stated

endpoints: verify device performance across the intended range of heart and respiratory rates

standards: IEC 60601-1:2005+ CORR. 1:2006 + CORR. 2:2007 + A1:2012, IEC 60601-1-2:2014, IEC 60825-1

Retrospective clinical

n=130 patients

endpoints: accuracy of heart rate for non-arrhythmia subjects; accuracy of respiratory rate for general population; equivalence of the Gili BioSensor System to reference device on heart rate for general population

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

Each value carries its own analysis unit and task — never compare or pool across devices. Source: De Novo decision summary PDF.

Predicate network

Postmarket — what happened after clearance

0
recalls in product code, 24mo
0
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
0
drift signals on this device

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-08-26.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to De Novo AI/ML devices in the Cardiovascular panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/DEN200038