# K231820: SoloSmart Injection Pen Adapter (SoloSmart®)

- Pathway: 510(k) (Special)
- Applicant: Biocorp Production
- Decided: Jan 12, 2024 after 205 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.
2 later devices descend 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)
- K222689: Mallya Injection Pen Adapter (Mallya® for Solostar®), Biocorp Production (2022) Summary page 4.

## Most influential descendants
- K250555: MallyaD injection pen adapter (MallyaD) (2025), 1 descendant of its own
- K251500: MallyaG Injection Pen Adapter (MallyaG) (2025), 0 descendants of its own

## Indications for use
The SoloSmart 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: DEVICE MODEL NAME | INSULIN BRAND NAME | MOLECULE NAME | MOLECULE CONCENTRATION | Lantus | | 100 IU/mL |_________________________| GLARGINE |_____________________________ | Toujeo | | 300 IU/mL SoloSmart |_________________________|____________________|_____________________________ designed for | Admelog | LISPRO | 100 IU/mL Solostar® SANOFI |_________________________|____________________|_____________________________ Injection pen | Apidra | GLULISINE | 100 IU/mL |_________________________|____________________|_____________________________ | Soliqua 100/33 | GLARGINE AND | 100 IU/mL | | LIXISENATIDE | +33mcg/mL

Source page: https://510kreport.com/device/K231820
Methodology: https://510kreport.com/methodology