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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 / June 2026 / K251326

510(k) cleared

Respiration Rate algorithm

Edwards Lifesciences, LLC · Jun 11, 2026 · K251326

FDA cleared the Respiration Rate algorithm from Edwards Lifesciences, LLC on Jun 11, 2026 under K251326, a traditional 510(k). The device falls under product code BZQ, Monitor, Breathing Frequency, regulated at 21 CFR 868.2375 as a Class 2 device. The review panel was Anesthesiology.

FDA logged the submission as received on Apr 29, 2025. The decision came 408 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)), K260105 (Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts), K254279 (Edwards eSheath+ introducer set), K253186 (HemoSphere Nano Monitor (HSNANO1)).

Questions & Answers

What did FDA clear under K251326?

K251326 is the FDA 510(k) for Respiration Rate algorithm, submitted by Edwards Lifesciences, LLC. FDA's decision date was Jun 11, 2026, under product code BZQ (Monitor, Breathing Frequency).

Who makes the Respiration Rate algorithm?

Edwards Lifesciences, LLC, based in Irvine, CA, is the applicant of record for K251326.

How long did the K251326 review take?

FDA received the submission on Apr 29, 2025 and issued its decision on Jun 11, 2026, 408 days later.

← All decisions in June 2026