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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 / September 2025 / K251982

510(k) cleared

Edwards MC3 Tricuspid annuloplasty ring (4900)

Edwards Lifesciences, LLC · Sep 23, 2025 · K251982

FDA cleared the Edwards MC3 Tricuspid annuloplasty ring (4900) from Edwards Lifesciences, LLC on Sep 23, 2025 under K251982, a abbreviated 510(k). The device falls under product code KRH, Ring, Annuloplasty, regulated at 21 CFR 870.3800 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jun 27, 2025. The decision came 88 days later, inside the 90 FDA-day goal for a 510(k).

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 K251982?

K251982 is the FDA 510(k) for Edwards MC3 Tricuspid annuloplasty ring (4900), submitted by Edwards Lifesciences, LLC. FDA's decision date was Sep 23, 2025, under product code KRH (Ring, Annuloplasty).

Who makes the Edwards MC3 Tricuspid annuloplasty ring (4900)?

Edwards Lifesciences, LLC, based in Irvine, CA, is the applicant of record for K251982.

How long did the K251982 review take?

FDA received the submission on Jun 27, 2025 and issued its decision on Sep 23, 2025, 88 days later.

← All decisions in September 2025