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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 / K253021

510(k) cleared

ANNE Maternal

Sibel Health, Inc. · Feb 26, 2026 · K253021

FDA cleared the ANNE Maternal from Sibel Health, Inc. on Feb 26, 2026 under K253021, a traditional 510(k). The device falls under product code HGM, System, Monitoring, Perinatal, regulated at 21 CFR 884.2740 as a Class 2 device. The review panel was Obstetrics/Gynecology.

FDA logged the submission as received on Sep 19, 2025. The decision came 160 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 Sibel Health, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253021?

K253021 is the FDA 510(k) for ANNE Maternal, submitted by Sibel Health, Inc.. FDA's decision date was Feb 26, 2026, under product code HGM (System, Monitoring, Perinatal).

Who makes the ANNE Maternal?

Sibel Health, Inc., based in Chicago, IL, is the applicant of record for K253021.

How long did the K253021 review take?

FDA received the submission on Sep 19, 2025 and issued its decision on Feb 26, 2026, 160 days later.

← All decisions in February 2026