Tempus ECG-AF

K233549

Tempus AI, Inc. · cleared 2024-06-21 · product code SBQ · Cardiovascular

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.1)
“Cardiovascular machine learning-based notification software”
Algorithmmachine learning-based notification software; trained and 'locked' machine-learning model
source quote (p.1)
“Cardiovascular machine learning-based notification software”
Adaptive (vs locked)No
source quote (p.6)
“analyzes the data via a trained and 'locked' machine-learning model”
PCCPNo
Cybersecurity addressedYes
source quote (p.7)
“The performance of Tempus ECG-AF was evaluated based on the non-clinical testing as follows: software verification and validation; and cybersecurity and human factors testing.”

Validation studies (1)

Retrospective clinical

n=4,017 patients · 3 site(s)

endpoints: sensitivity; specificity

Reported performance (4 observations)

sensitivity0.31CI 95% CI of 25% - 37%
source quote (p.7)
“Study endpoints of sensitivity and specificity were met, with an observed sensitivity of 31% (95% CI of 25% - 37%)”
specificity0.92CI 95% CI of 91%-92%
source quote (p.7)
“and specificity of 92% (95% CI of 91%-92%).”
ppvas written: “Positive Predictive Value (PPV)”0.19CI 95% CI of 15% - 23%
source quote (p.7)
“The positive predictive value (PPV) observed in the study was 19% (95% CI of 15% - 23%)”
npvas written: “Negative Predictive Value (NPV)”0.95CI 95% CI of 95% - 96%
source quote (p.7)
“and the negative predictive value (NPV) was 95% (95% CI of 95% - 96%).”

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) K250119 (decision 2025-07-15) from Tempus AI, Inc. for a matching device line ("Tempus ECG-Low EF") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K250119

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/K233549