Ryurei
K-Number: K252295 · 2026-03-27
ApplicantTerumo Corporation
Decision Date2026-03-27
Product CodeLOX
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Ryurei is a medical device manufactured by Terumo Corporation. It received FDA 510(k) clearance on 2026-03-27 under approval number K252295. The device is classified under product code LOX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Ryurei?
Ryurei is a medical device that received FDA 510(k) clearance on 2026-03-27. It is manufactured by Terumo Corporation. The 510(k) number is K252295.
When was Ryurei approved by the FDA?
Ryurei received FDA 510(k) clearance on 2026-03-27, under approval number K252295.
What company makes Ryurei?
Ryurei is manufactured by Terumo Corporation.
What is the FDA product code for Ryurei?
The FDA product code for Ryurei is LOX.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.