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FDA 510(k)

SmartPilot YpsoMate NS-A2.25

K-Number: K243901 · 2025-08-28

ApplicantYpsomed AG
Decision Date2025-08-28
Product CodeQOG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SmartPilot YpsoMate NS-A2.25 is the device name listed in this FDA 510(k) record. The listed applicant is Ypsomed AG. It received FDA 510(k) clearance on 2025-08-28 under 510(k) number K243901. The device is classified under product code QOG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SmartPilot YpsoMate NS-A2.25?

SmartPilot YpsoMate NS-A2.25 is a medical device that received FDA 510(k) clearance on 2025-08-28. The listed applicant is Ypsomed AG. The 510(k) number is K243901.

When did SmartPilot YpsoMate NS-A2.25 receive FDA 510(k) clearance?

SmartPilot YpsoMate NS-A2.25 received FDA 510(k) clearance on 2025-08-28, under 510(k) number K243901.

Who is the listed applicant for SmartPilot YpsoMate NS-A2.25?

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

What is the FDA product code for SmartPilot YpsoMate NS-A2.25?

The FDA product code for SmartPilot YpsoMate NS-A2.25 is QOG.

Other records listing Ypsomed AG 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.

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Related Devices (Code: QOG)

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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.

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