Cleared Traditional

PreemptiveAI Clinical SDK

K250233 · Measure Labs, Inc. (Dba Preemptiveai, Inc.) · Cardiovascular

Feb 2026

Decision

382d

Days

Class 2

Risk

About This 510(k) Submission

K250233 is an FDA 510(k) clearance for the PreemptiveAI Clinical SDK, a Transmitters And Receivers, Electrocardiograph, Telephone (Class II — Special Controls, product code DXH), submitted by Measure Labs, Inc. (Dba Preemptiveai, Inc.) (Seattle, US). The FDA issued a Cleared decision on February 13, 2026, 382 days after receiving the submission on January 27, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2920.

Submission Details

510(k) Number	K250233 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 27, 2025
Decision Date	February 13, 2026
Days to Decision	382 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF