Oxehealth Vital Signs

K220899

Oxehealth Limited · cleared 2022-04-29 · product code QME · Cardiovascular

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.3)
“The Oxehealth Vital Signs device is intended for noninvasive spot measurement of pulse rate and estimated breathing rate (chest wall movements) when the subject is still. It is software assessing video footage from a fixed-installation solution for use within single occupancy rooms within hospitals, general care and secured environments with professional healthcare oversight and where a framework exists which mandates periodic checks by a trained professional to ensure subject safety.”
Algorithmproprietary software-controlled algorithms
source quote (p.5)
“When run through proprietary software- controlled algorithms, the software will allow a user to make spot checks for pulse and breathing rates of the individual in the room.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.6)
“(v) Software documentation must include a cybersecurity vulnerability and management process to assure software functionality.”

Validation studies (2)

Bench

sample size not stated

Retrospective clinical

sample size not stated

endpoints: statistical non-inferiority for pulse rate; statistical non-inferiority for breathing rate

Reported performance (1 observation)

accuracyas written: “Pulse rate accuracy limitation”stated without value
source quote (p.10)
“Pulse rate accuracy may be reduced when the subject has a pulse rate greater than 110 beats per minute.”

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
2
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

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K243687 (decision 2025-08-27) 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:K243687

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/K220899