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FDA 510(k)

Ryurei

K-Number: K252295 · 2026-03-27

ApplicantTerumo Corporation
Decision Date2026-03-27
Product CodeLOX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Ryurei is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Corporation. It received FDA 510(k) clearance on 2026-03-27 under 510(k) 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. The listed applicant is Terumo Corporation. The 510(k) number is K252295.

When did Ryurei receive FDA 510(k) clearance?

Ryurei received FDA 510(k) clearance on 2026-03-27, under 510(k) number K252295.

Who is the listed applicant for Ryurei?

The FDA 510(k) record lists Terumo Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ryurei?

The FDA product code for Ryurei is LOX.

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Related Devices (Code: 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.

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