# K222689: Mallya Injection Pen Adapter (Mallya® for Solostar®)

- Pathway: 510(k) (Traditional)
- Applicant: Biocorp Production
- Decided: Dec 5, 2022 after 90 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: 8 generations back to K010362 (2001). 16 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160629: InPen, Companion Medical, Inc. (2016) Summary page 4.

## Most influential descendants
- K231820: SoloSmart Injection Pen Adapter (SoloSmart®) (2024), 2 descendants of its own
- K250555: MallyaD injection pen adapter (MallyaD) (2025), 1 descendant of its own
- K243901: SmartPilot YpsoMate NS-A2.25 (2025), 0 descendants of its own
- K251500: MallyaG Injection Pen Adapter (MallyaG) (2025), 0 descendants of its own

## Indications for use
The Mallya Injection Pen Adapter is indicated for the capture and wireless transmission of dosing information from compatible reusable and disposable pen injectors. The following Injection pens are compatible. Mallya designed for Solostar® SANOFI injection pen: Lantus, Toujeo, Admelog, Apidra, and Soliqua 100/33.

Source page: https://510kreport.com/device/K222689
Methodology: https://510kreport.com/methodology