Vital Signs

K243687

Oxehealth Limited · cleared 2025-08-27 · 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 retrospective monitoring of non-contact pulse rate and respiratory rate data derived from video, without the need for contact devices to be attached to the patient or bed.”
AlgorithmProprietary software-controlled algorithms are used to derive patient spot heart rate and respiratory rate data from the analysis of video data, using Machine Learning techniques.
source quote (p.6)
“Proprietary software-controlled algorithms are used to derive patient spot heart rate and respiratory rate data from the analysis of this video data, once the user has followed a workflow to initiate the system's data analysis. It uses the same methods of Vital sign detection and the same Machine Learning techniques as the predicate device (K211906).”
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 (1)

Retrospective clinical

n=30 patients

endpoints: heart rate MAE; respiratory rate MAE; pulse rate validation; respiratory rate validation

standards: ISO 14971:2019 + A11:2021, AAMI BS 34971:2022, IEC 62304:2006 + A1:2015, IEC 82304-1:2016, IEC 80001-1:2021, IEC 81001-5-1:2021, IEC/TR 80002-1:2009, IEC 62366-1:2015 +A1:2020, ISO 15223-1:2021, ISO 20417:2021

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
1
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K251200 (decision 2026-02-02) from Oxehealth Limited for a matching device line ("Vital Signs") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K251200

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/K243687