510(k) · Cardiovascular

PreemptiveAI Clinical SDK

by Measure Labs, Inc. (Dba Preemptiveai, Inc.)

PreemptiveAI Clinical SDK is an AI-enabled medical device from Measure Labs, Inc. (Dba Preemptiveai, Inc.) that the U.S. FDA cleared through 510(k) K250233 on February 13, 2026. Its lead review panel is Cardiovascular and its primary product code is DXH (Transmitters And Receivers, Electrocardiograph, Telephone).

See also FDA-cleared AI cardiovascular devices in 2026, all FDA AI clearances in 2026, top cardiovascular AI devices.

Key facts

Submission numberK250233
Pathway510(k)
Date of final decision
Company (FDA list)Measure Labs, Inc. (Dba Preemptiveai, Inc.)
Lead review panelCardiovascular
Primary product codeDXH — Transmitters And Receivers, Electrocardiograph, Telephone
Applicant (openFDA)Measure Labs, Inc. (Dba Preemptiveai, Inc.)
Applicant locationSeattle, WA, US
Device classClass 2
Regulation number21 CFR 870.2920
Decision codeSESE
Submission typeTraditional

Source: FDA AI-Enabled Medical Devices list and openFDA.

What this means

A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. PreemptiveAI Clinical SDK went through this pathway (K250233).

openFDA lists it as a Class 2 device under 21 CFR 870.2920. Class II devices are moderate risk and are subject to general and special controls.

Product code DXH covers 6 devices on the FDA AI list. By decision date, this device is #6 of 6 under that code. Measure Labs, Inc. (Dba Preemptiveai, Inc.) has 1 AI-enabled device on the list, and the Cardiovascular panel accounts for 154 in total.

Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.

Similar devices (product code DXH)