FDA 510(k)

Sunrise

K-Number: K250874 · 2025-08-29

Decision Date2025-08-29

Product CodeQRS

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

Sunrise is the device name listed in this FDA 510(k) record. The listed applicant is Sunrise SA. It received FDA 510(k) clearance on 2025-08-29 under 510(k) number K250874. The device is classified under product code QRS. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sunrise?

Sunrise is a medical device that received FDA 510(k) clearance on 2025-08-29. The listed applicant is Sunrise SA. The 510(k) number is K250874.

When did Sunrise receive FDA 510(k) clearance?

Sunrise received FDA 510(k) clearance on 2025-08-29, under 510(k) number K250874.

Who is the listed applicant for Sunrise?

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

What is the FDA product code for Sunrise?

The FDA product code for Sunrise is QRS.

Other records listing Sunrise SA as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K222262Sunrise

Related Devices (Code: QRS)

K222262SunriseSunrise SA

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.