Cleared Traditional

SmartPilot YpsoMate NS-A2.25

K243901 · Ypsomed AG · General Hospital

Aug 2025

Decision

252d

Days

Class 2

Risk

About This 510(k) Submission

K243901 is an FDA 510(k) clearance for the SmartPilot YpsoMate NS-A2.25, a Injection Data Capture Device (Class II — Special Controls, product code QOG), submitted by Ypsomed AG (Burgdorf, CH). The FDA issued a Cleared decision on August 28, 2025, 252 days after receiving the submission on December 19, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number	K243901 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 19, 2024
Decision Date	August 28, 2025
Days to Decision	252 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	QOG — Injection Data Capture Device
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.5860
Definition	An Injection Data Capture Device Is An Electrically-powered/electromechanical Accessory That Interfaces With Reusable Or Disposable Injection Devices For The Purposes Of Interpreting, Recording And Displaying And/or Transmitting Injection Data To A Connected Application Or Software.