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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 / August 2026 / K253985

510(k) cleared

INNOVANCE® D-Dimer 2.0 (SMN 10873803)

Siemens Healthcare Diagnostic Products GmbH · Aug 11, 2026 · K253985

FDA cleared the INNOVANCE® D-Dimer 2.0 (SMN 10873803) from Siemens Healthcare Diagnostic Products GmbH on Aug 11, 2026 under K253985, a traditional 510(k). The device falls under product code DAP, Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control, regulated at 21 CFR 864.7320 as a Class 2 device. The review panel was Hematology.

FDA logged the submission as received on Dec 12, 2025. The decision came 242 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Siemens Healthcare Diagnostic Products GmbH has 8 other decisions in the tracker over the last 12 months: K253528 (Atellica IM CA 19-9 II), K261364 (Atellica CH Acetaminophen 2 (ACTM)), K253264 (myAblation Guide (VC10A)), P250026 (Atellica IM free PSA II (fPSAII)).

Questions & Answers

What did FDA clear under K253985?

K253985 is the FDA 510(k) for INNOVANCE® D-Dimer 2.0 (SMN 10873803), submitted by Siemens Healthcare Diagnostic Products GmbH. FDA's decision date was Aug 11, 2026, under product code DAP (Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control).

Who makes the INNOVANCE® D-Dimer 2.0 (SMN 10873803)?

Siemens Healthcare Diagnostic Products GmbH, based in Marburg, is the applicant of record for K253985.

How long did the K253985 review take?

FDA received the submission on Dec 12, 2025 and issued its decision on Aug 11, 2026, 242 days later.

← All decisions in August 2026