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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

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.

Diagnostica Stago, Inc. has one other decision in the tracker over the last 12 months: K260214 (STA® - Liquid Anti-Xa).

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

Sources