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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 / February 2026 / K253186

510(k) cleared

HemoSphere Nano Monitor (HSNANO1)

Edwards Lifesciences, LLC · Feb 24, 2026 · K253186

FDA cleared the HemoSphere Nano Monitor (HSNANO1) from Edwards Lifesciences, LLC on Feb 24, 2026 under K253186, 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 Sep 26, 2025. The decision came 151 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Edwards Lifesciences, LLC 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 K253186?

K253186 is the FDA 510(k) for HemoSphere Nano Monitor (HSNANO1), submitted by Edwards Lifesciences, LLC. FDA's decision date was Feb 24, 2026, under product code DQK (Computer, Diagnostic, Programmable).

Who makes the HemoSphere Nano Monitor (HSNANO1)?

Edwards Lifesciences, LLC, based in Irvine, CA, is the applicant of record for K253186.

How long did the K253186 review take?

FDA received the submission on Sep 26, 2025 and issued its decision on Feb 24, 2026, 151 days later.

← All decisions in February 2026