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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 / October 2025 / K253034

510(k) cleared

HemoSphere Stream Module

Edwards Lifesciences · Oct 21, 2025 · K253034

FDA cleared the HemoSphere Stream Module from Edwards Lifesciences on Oct 21, 2025 under K253034, a special 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 Sep 22, 2025. The decision came 29 days later, inside the 90 FDA-day goal for a 510(k).

Edwards Lifesciences has 8 other decisions in the tracker over the last 12 months: K254232 (ECLIPTIS Left Atrial Appendage Exclusion System (ECS135); ECLIPTIS Left Atrial Appendage Exclusion System (ECS140); ECLIPTIS Left Atrial Appendage Exclusion System (ECS145); ECLIPTIS Left Atrial Appendage Exclusion System (ECS150)), K251326 (Respiration Rate algorithm), K260105 (Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts), K254279 (Edwards eSheath+ introducer set).

Questions & Answers

What did FDA clear under K253034?

K253034 is the FDA 510(k) for HemoSphere Stream Module, submitted by Edwards Lifesciences. FDA's decision date was Oct 21, 2025, under product code DQK (Computer, Diagnostic, Programmable).

Who makes the HemoSphere Stream Module?

Edwards Lifesciences, based in Irvine, CA, is the applicant of record for K253034.

How long did the K253034 review take?

FDA received the submission on Sep 22, 2025 and issued its decision on Oct 21, 2025, 29 days later.

← All decisions in October 2025