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510(k) K243901

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

K243901 is an FDA 510(k) premarket notification submitted by Ypsomed AG for the device "SmartPilot YpsoMate NS-A2.25". The FDA issued a decision of Substantially Equivalent on August 28, 2025. The device falls under product code QOG (Injection Data Capture Device), a Class II device regulated under 21 CFR 880.5860. Ypsomed AG has at least 10 other 510(k) clearances on record.

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.

Other clearances by Ypsomed AG

  • K171984 — Clickfine Pen Needle, Penfine Classic Pen Needle (October 11, 2017)
  • K163400 — Orbit Inserter (July 26, 2017)
  • K150921 — Orbit Infusion Set (April 12, 2016)
  • K152514 — Clickfine AutoProtect Pen Needle (November 18, 2015)
  • 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)

FDA data resources