Vital Signs

K211906

Oxehealth Limited · cleared 2021-07-20 · product code QME · Cardiovascular

Premarket evidence — what FDA accepted

Device typesimd
source quote (p.7)
“Oxehealth Vital Signs is a software only medical device, intended to run on standard, off the shelf computing hardware with an off the shelf video camera and infrared illuminator.”
Algorithmproprietary software-controlled algorithms designed to extract signals from video to and measure pulse rate and breathing rate from a patient
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)
“Software documentation must include a cybersecurity vulnerability and management process to assure software functionality.”

Validation studies (2)

Retrospective clinical

sample size not stated

Bench

sample size not stated

Reported performance (2 observations)

accuracyas written: “Pulse rate measurement accuracy”stated without valueCI ± 3 beats per minute
source quote (p.9)
“Pulse rate measurement 50 to 130 ± 3 beats per minute*, 9 second measurement window.”
accuracyas written: “Estimated breathing rate measurement accuracy”stated without valueCI ± 2 breaths per minute
source quote (p.9)
“Estimated breathing rate (chest wall movements) measurement 8 to 31 ± 2 breaths per minute*, 30 second measurement window.”

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
3
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

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K220899 (decision 2022-04-29) from Oxehealth Limited for a matching device line ("Oxehealth Vital Signs") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K220899

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/K211906