Vital Signs

K251200

Oxehealth Limited · cleared 2026-02-02 · product code QME · Cardiovascular

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.6)
“Vital Signs is a software-only medical device (SaMD) that provides non-contact pulse rate and breathing rate (chest wall movements) data derived from video, without the need for contact devices to be attached to the patient or bed.”
AlgorithmProprietary software-controlled algorithms
source quote (p.6)
“Proprietary software-controlled algorithms are used to derive patient spot heart rate and breathing rate data from the analysis of this video data, once the user has followed a workflow to initiate the system's data analysis.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.7)
“The firm has also performed penetration and vulnerability testing in line with FDA's guidance on cybersecurity.”

Validation studies (0)

FDA source did not describe a validation study.

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/K251200