510(k) K243901

SmartPilot YpsoMate NS-A2.25 by Ypsomed AG — Product Code QOG

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: August 28, 2025
Date Received: December 19, 2024
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Injection Data Capture Device
Device Class: Class II
Regulation Number: 880.5860
Review Panel: HO
Submission Type

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.

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K150662 — Clickfine Pen Needle, Penfine Classic Pen Needle (other trade names anticipated) (June 9, 2015)
K131123 — CLICKFINE AUTOPROTECT PEN NEEDLE (July 5, 2013)
K131125 — CLICKFINE PEN NEEDLE (July 5, 2013)
K130468 — ORBIT INFUSION SET (March 19, 2013)
K110312 — CLICKFINE AUTOPROTECT PEN NEEDLE (January 26, 2012)
K102108 — CLICKFINE PEN NEEDLE (November 23, 2010)

Other clearances for product code QOG

K251500 — MallyaG Injection Pen Adapter (MallyaG) (June 9, 2025)
K250555 — MallyaD injection pen adapter (MallyaD) (March 27, 2025)
K241803 — INSULCLOCK® v2.0 PRO (August 22, 2024)
K231820 — SoloSmart Injection Pen Adapter (SoloSmart®) (January 12, 2024)
K222689 — Mallya Injection Pen Adapter (Mallya® for Solostar®) (December 5, 2022)
K212217 — Tempo Smart Button (September 16, 2022)