FDA cleared the HeartBeam AIMIGo with 12-L ECG Synthesis Software System from Heartbeam, Inc. on Dec 8, 2025 under K250258, a traditional 510(k). The device falls under product code DXH, Transmitters And Receivers, Electrocardiograph, Telephone, regulated at 21 CFR 870.2920 as a Class 2 device. The review panel was Cardiovascular.
FDA logged the submission as received on Jan 28, 2025. The decision came 314 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.
This is the only decision on file for Heartbeam, Inc. in the last 12 months of the tracker.
Questions & Answers
What did FDA clear under K250258?
K250258 is the FDA 510(k) for HeartBeam AIMIGo with 12-L ECG Synthesis Software System, submitted by Heartbeam, Inc.. FDA's decision date was Dec 8, 2025, under product code DXH (Transmitters And Receivers, Electrocardiograph, Telephone).
Who makes the HeartBeam AIMIGo with 12-L ECG Synthesis Software System?
Heartbeam, Inc., based in Santa Clara, CA, is the applicant of record for K250258. The company is listed in the MedDevice Startups directory.
How long did the K250258 review take?
FDA received the submission on Jan 28, 2025 and issued its decision on Dec 8, 2025, 314 days later.