FaceHeart Vitals Software Development Kit (FH vitals SDK)

K223622

FaceHeart Corp. · cleared 2023-09-01 · product code QME · Cardiovascular

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.5)
“FH vitals SDK is a video-based, non-contact pulse rate measurement software with a face recognition function designed to measure and real-time display the pulse rate of adults.”
AlgorithmThe device uses signal processing and an algorithm to compute pulse rate from continuous face image data captured by cameras.
source quote (p.5)
“This system uses cameras to detect the user's face and obtains the continuous face image data, with signal processing and algorithm to compute the pulse rate.”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedYes
source quote (p.12)
“Software documentation also included cybersecurity testing and a vulnerability analysis.”

Validation studies (1)

Retrospective clinical

n=527 patients

endpoints: pulse rate deviation within ±3bpm

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: 510(k) 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 2026-07-08.

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 510(k) 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/K223622