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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 / May 2026 / K250781

510(k) cleared

Embryo Predict

Alife Health · May 15, 2026 · K250781

FDA cleared the Embryo Predict from Alife Health on May 15, 2026 under K250781, a traditional 510(k). The device falls under product code PBH, Embryo Image Assessment System, Assisted Reproduction, regulated at 21 CFR 884.6195 as a Class 2 device. The review panel was Obstetrics/Gynecology.

FDA logged the submission as received on Mar 14, 2025. The decision came 427 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 Alife Health in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250781?

K250781 is the FDA 510(k) for Embryo Predict, submitted by Alife Health. FDA's decision date was May 15, 2026, under product code PBH (Embryo Image Assessment System, Assisted Reproduction).

Who makes the Embryo Predict?

Alife Health, based in Cambridge, MA, is the applicant of record for K250781.

How long did the K250781 review take?

FDA received the submission on Mar 14, 2025 and issued its decision on May 15, 2026, 427 days later.

← All decisions in May 2026