# K241803: INSULCLOCK® v2.0 PRO

- Pathway: 510(k) (Traditional)
- Applicant: Insulcloud S.L.
- Decided: Aug 22, 2024 after 62 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)
- K212217: Tempo Smart Button, Eli Lilly and Company (2022) Summary page 4.

## Indications for use
- Insulclock® is for use by patients using disposable insulin diagnosed with type I or type II diabetes mellitus. - Insulclock® is for use by people from 18 to 65 years old. Out of this age range, the Insulclock® must be used under supervision. - Insulclock® is designed for use in any home environment. - Using a compatible App.

Source page: https://510kreport.com/device/K241803
Methodology: https://510kreport.com/methodology