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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 / April 2026 / K253658

510(k) cleared

STA Satellite Max®

Diagnostica Stago, Inc. · Apr 27, 2026 · K253658

FDA cleared the STA Satellite Max® from Diagnostica Stago, Inc. on Apr 27, 2026 under K253658, a traditional 510(k). The device falls under product code JPA, System, Multipurpose For In Vitro Coagulation Studies, regulated at 21 CFR 864.5425 as a Class 2 device. The review panel was Hematology.

FDA logged the submission as received on Nov 20, 2025. The decision came 158 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 Diagnostica Stago, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253658?

K253658 is the FDA 510(k) for STA Satellite Max®, submitted by Diagnostica Stago, Inc.. FDA's decision date was Apr 27, 2026, under product code JPA (System, Multipurpose For In Vitro Coagulation Studies).

Who makes the STA Satellite Max®?

Diagnostica Stago, Inc., based in Parsippany, NJ, is the applicant of record for K253658.

How long did the K253658 review take?

FDA received the submission on Nov 20, 2025 and issued its decision on Apr 27, 2026, 158 days later.

← All decisions in April 2026