# K243901: SmartPilot YpsoMate NS-A2.25

- Pathway: 510(k) (Traditional)
- Applicant: Ypsomed AG
- Decided: Aug 28, 2025 after 252 days
- Product code: QOG (Injection Data Capture Device)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K010362 (2001). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222689: Mallya Injection Pen Adapter (Mallya® for Solostar®), Biocorp Production (2022) Summary page 5.

## Indications for use
The SmartPilot YpsoMate NS-A2.25 is indicated for use with the compatible disposable autoinjector to capture and record injection information that provides feedback to the user.

Source page: https://510kreport.com/device/K243901
Methodology: https://510kreport.com/methodology