Devices · Measure Labs, Inc. (Dba Preemptiveai, Inc.)

PreemptiveAI Clinical SDK

510(k)K250233CardiovascularDXH

Measure Labs, Inc. (Dba Preemptiveai, Inc.) is listed for PreemptiveAI Clinical SDK (K250233). The FDA list gives February 13, 2026 as the date of the final decision. The lead panel is Cardiovascular, and the database link on the FDA list is the 510(k) pathway. The primary product code on the FDA list is DXH. openFDA did not return a classification record for that code in this copy of the data. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250233

Official FDA database record

Date of final decision: February 13, 2026
Company on the FDA list: Measure Labs, Inc. (Dba Preemptiveai, Inc.)
Lead panel: Cardiovascular
Primary product code: DXH
openFDA device name for the code: Transmitters And Receivers, Electrocardiograph, Telephone
Device class: 2
Regulation number: 870.2920
openFDA decision description: Substantially Equivalent
openFDA decision code: SESE
Statement or summary label: Summary