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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / February 2026 / K250233

510(k) cleared

PreemptiveAI Clinical SDK

Measure Labs, Inc. (Dba Preemptiveai, Inc.) · Feb 13, 2026 · K250233

FDA cleared the PreemptiveAI Clinical SDK from Measure Labs, Inc. (Dba Preemptiveai, Inc.) on Feb 13, 2026 under K250233, 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 27, 2025. The decision came 382 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 Measure Labs, Inc. (Dba Preemptiveai, Inc.) in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250233?

K250233 is the FDA 510(k) for PreemptiveAI Clinical SDK, submitted by Measure Labs, Inc. (Dba Preemptiveai, Inc.). FDA's decision date was Feb 13, 2026, under product code DXH (Transmitters And Receivers, Electrocardiograph, Telephone).

Who makes the PreemptiveAI Clinical SDK?

Measure Labs, Inc. (Dba Preemptiveai, Inc.), based in Seattle, WA, is the applicant of record for K250233.

How long did the K250233 review take?

FDA received the submission on Jan 27, 2025 and issued its decision on Feb 13, 2026, 382 days later.

← All decisions in February 2026