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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 / July 2026 / K253576

510(k) cleared

CorVista System® with PCWP Add-On

Analytics For Life, Inc. · Jul 26, 2026 · K253576

FDA cleared the CorVista System® with PCWP Add-On from Analytics For Life, Inc. on Jul 26, 2026 under K253576, a traditional 510(k). The device falls under product code DQK, Computer, Diagnostic, Programmable, regulated at 21 CFR 870.1425 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Nov 17, 2025. The decision came 251 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 Analytics For Life, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253576?

K253576 is the FDA 510(k) for CorVista System® with PCWP Add-On, submitted by Analytics For Life, Inc.. FDA's decision date was Jul 26, 2026, under product code DQK (Computer, Diagnostic, Programmable).

Who makes the CorVista System® with PCWP Add-On?

Analytics For Life, Inc., based in Bethesda, MD, is the applicant of record for K253576.

How long did the K253576 review take?

FDA received the submission on Nov 17, 2025 and issued its decision on Jul 26, 2026, 251 days later.

← All decisions in July 2026