# K250555: MallyaD injection pen adapter (MallyaD)

- Pathway: 510(k) (Special)
- Applicant: Biocorp Production
- Decided: Mar 27, 2025 after 30 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: 10 generations back to K010362 (2001). 18 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231820: SoloSmart Injection Pen Adapter (SoloSmart®), Biocorp Production (2024) Summary page 5.

## Most influential descendants
- K251500: MallyaG Injection Pen Adapter (MallyaG) (2025), 0 descendants of its own

## Indications for use
The MallyaD 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 diabetes treatment are: - insulin degludec molecule (Tresiba U-100 FlexTouch and Tresiba U-200 FlexTouch) - insulin aspart molecule (Fiasp FlexTouch) - insulin degludec and liraglutide molecules (Xultophy)

Source page: https://510kreport.com/device/K250555
Methodology: https://510kreport.com/methodology