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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 / K251688

510(k) cleared

Carpentier-Edwards Physio Annuloplasty Ring (4450)

Edwards Lifesciences, LLC · Sep 17, 2025 · K251688

FDA cleared the Carpentier-Edwards Physio Annuloplasty Ring (4450) from Edwards Lifesciences, LLC on Sep 17, 2025 under K251688, 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 2, 2025. The decision came 107 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 K251688?

K251688 is the FDA 510(k) for Carpentier-Edwards Physio Annuloplasty Ring (4450), submitted by Edwards Lifesciences, LLC. FDA's decision date was Sep 17, 2025, under product code KRH (Ring, Annuloplasty).

Who makes the Carpentier-Edwards Physio Annuloplasty Ring (4450)?

Edwards Lifesciences, LLC, based in Irvine, CA, is the applicant of record for K251688.

How long did the K251688 review take?

FDA received the submission on Jun 2, 2025 and issued its decision on Sep 17, 2025, 107 days later.

← All decisions in September 2025