# K251500: MallyaG Injection Pen Adapter (MallyaG)

- Pathway: 510(k) (Special)
- Applicant: Biocorp Production
- Decided: Jun 9, 2025 after 25 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: 11 generations back to K010362 (2001). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K250555: MallyaD injection pen adapter (MallyaD), Biocorp Production (2025) Summary page 5.

## Indications for use
The MallyaG Injection Pen Adapter is indicated for the capture and wireless transmission of dosing information of compatible reusable and disposable pen injectors. The Novo Nordisk PDS290 Injection pens compatible for growth disorder treatment are: - Sogroya (somapacitan-beco) - Norditropin FlexPro

Source page: https://510kreport.com/device/K251500
Methodology: https://510kreport.com/methodology