FDA 510(k)

SmartPilot YpsoMate NS-A2.25

K-Number: K243901 · 2025-08-28

Decision Date2025-08-28

Product CodeQOG

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

SmartPilot YpsoMate NS-A2.25 is a medical device manufactured by Ypsomed AG. It received FDA 510(k) clearance on 2025-08-28 under approval 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. It is manufactured by Ypsomed AG. The 510(k) number is K243901.

When was SmartPilot YpsoMate NS-A2.25 approved by the FDA?

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

What company makes SmartPilot YpsoMate NS-A2.25?

SmartPilot YpsoMate NS-A2.25 is manufactured by Ypsomed AG.

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 Devices by Ypsomed AG

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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.