SmartPilot YpsoMate NS-A2.25
FDA 510(k) K243901 · Ypsomed AG
510(k) numberK243901
Submission
- Device name
- SmartPilot YpsoMate NS-A2.25
- Applicant
- Ypsomed AG
Burgdorf, CH - Received
- December 19, 2024
- Decision date
- August 28, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QOG – Injection Data Capture Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5860
- Specialty
- General Hospital
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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|---|---|---|---|
| K251500 | MallyaG Injection Pen Adapter (MallyaG)QOG · Special | Biocorp Production | 06/09/2025SE |
| K250555 | MallyaD injection pen adapter (MallyaD)QOG · Special | Biocorp Production | 03/27/2025SE |
| K241803 | INSULCLOCK® v2.0 PROQOG · Traditional | Insulcloud S.L. | 08/22/2024SE |
| K231820 | SoloSmart Injection Pen Adapter (SoloSmart®)QOG · Special | Biocorp Production | 01/12/2024SE |
| K222689 | Mallya Injection Pen Adapter (Mallya® for Solostar®)QOG · Traditional | Biocorp Production | 12/05/2022SE |
| K212217 | Tempo Smart ButtonQOG · Traditional | Eli Lilly and Company | 09/16/2022SE |
More from Eli Lilly and Company
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|---|---|---|
| K171984 | Clickfine Pen Needle, Penfine Classic Pen NeedleFMI · Special | 10/11/2017SE |
| K163400 | Orbit InserterKZH · Traditional | 07/26/2017SE |
| K150921 | Orbit Infusion SetFPA · Traditional | 04/12/2016SE |
| K152514 | Clickfine AutoProtect Pen NeedleFMI · Special | 11/18/2015SE |
| K150662 | Clickfine Pen Needle, Penfine Classic Pen Needle (other trade names anticipated)FMI · Special | 06/09/2015SE |
| K131125 | Clickfine Pen NeedleFMI · Traditional | 07/05/2013SE |
| K131123 | Clickfine Autoprotect Pen NeedleFMI · Traditional | 07/05/2013SE |
| K130468 | Orbit Infusion SetFPA · Special | 03/19/2013SE |
| K110312 | Clickfine Autoprotect Pen NeedleFMI · Traditional | 01/26/2012SE |
| K102108 | Clickfine Pen NeedleFMI · Special | 11/23/2010SE |
Questions and answers
When was SmartPilot YpsoMate NS-A2.25 cleared by the FDA?
SmartPilot YpsoMate NS-A2.25 (K243901) received a 510(k) decision of Substantially Equivalent on August 28, 2025, 252 days after the submission was received.
What is the product code of K243901?
The FDA product code is QOG – Injection Data Capture Device, a Class II (moderate risk) device regulated under 21 CFR 880.5860.