# K212217: Tempo Smart Button

- Pathway: 510(k) (Traditional)
- Applicant: Eli Lilly and Company
- Decided: Sep 16, 2022 after 427 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.
1 later device descends from it; 1 cites it directly.
0 of 18 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
- K241803: INSULCLOCK® v2.0 PRO (2024), 0 descendants of its own

## Indications for use
The Tempo Smart Button is intended to detect, store, and transfer insulin dose-related data from a Tempo Pen to a compatible application such as the myTempo App (App). The Tempo Smart Button is indicated for single-patient use by patients 18 years or older who are: » diagnosed with type 1 or type 2 diabetes mellitus, * using prefilled insulin Tempo Pens [Basaglar® Tempo Pen (insulin glargine) injection 100 units/mL, Lyumjev® Tempo Pen (insulin lispro-aabc) injection 100 units/mL, Humalog® Tempo Pen (insulin lispro injection) 100 units/mL], * using a compatible application (App).

Source page: https://510kreport.com/device/K212217
Methodology: https://510kreport.com/methodology