WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Exit Postmarket & security

THE TAPE

FDA makes the Draeger VentStar Resus Neo hose removal a Class I recall Control Bionics wins a Class I CE mark for the NeuroStrip muscle sensor Medicare starts paying for Carlsmed Aprevo lumbar fusion under three new codes ABK Biomedical breaks ground on a Missouri plant for its Y90 microspheres Boston Scientific releases the last $8M from Elutia's BioEnvelope sale BlueWind gets a Category I CPT code for subfascial tibial neuromodulation Emboline runs its first US commercial Emboliner cases at Columbia SedMed raises $4M for a toilet lift that runs without power CDRH plans 11 final guidances in FY2027 and puts AI lifecycle management first FDA makes the Draeger VentStar Resus Neo hose removal a Class I recall Control Bionics wins a Class I CE mark for the NeuroStrip muscle sensor Medicare starts paying for Carlsmed Aprevo lumbar fusion under three new codes ABK Biomedical breaks ground on a Missouri plant for its Y90 microspheres Boston Scientific releases the last $8M from Elutia's BioEnvelope sale BlueWind gets a Category I CPT code for subfascial tibial neuromodulation Emboline runs its first US commercial Emboliner cases at Columbia SedMed raises $4M for a toilet lift that runs without power CDRH plans 11 final guidances in FY2027 and puts AI lifecycle management first

The Tracker / September 2026 / K254297

510(k) cleared

Tempus ECG-MR

Tempus AI, Inc. · Sep 25, 2026 · K254297

FDA cleared the Tempus ECG-MR from Tempus AI, Inc. on Sep 25, 2026 under K254297, a traditional 510(k). The device falls under product code SBQ, Atrial Fibrillation Risk Prediction Machine Learning-Based Notification Software, regulated at 21 CFR 870.2380 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Dec 31, 2025. The decision came 268 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Tempus AI, Inc. has one other decision in the tracker over the last 12 months: K253699 (Tempus ECG-PH).

Questions & Answers

What did FDA clear under K254297?

K254297 is the FDA 510(k) for Tempus ECG-MR, submitted by Tempus AI, Inc.. FDA's decision date was Sep 25, 2026, under product code SBQ (Atrial Fibrillation Risk Prediction Machine Learning-Based Notification Software).

Who makes the Tempus ECG-MR?

Tempus AI, Inc., based in Chicago, IL, is the applicant of record for K254297.

How long did the K254297 review take?

FDA received the submission on Dec 31, 2025 and issued its decision on Sep 25, 2026, 268 days later.

← All decisions in September 2026

Sources