# K060876: Accu-Chek Insulin Pump Configuration Software (Standard), Model 04625137001; Accu-Chek Insulin Pump Configuration Softwa

- Pathway: 510(k) (Traditional)
- Applicant: Disetronic Medical Systems AG
- Decided: Jun 15, 2006 after 76 days
- Product code: LZG (Pump, Infusion, Insulin)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K031390 (2003). 3 ancestors in all.
38 later devices descend from it; 1 cites it directly.
1 of 42 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042887: Accu-Chek Spirit, Disetronic Medical Systems AG (2005) Summary page 2.

## Most influential descendants
- K111353: Accu-Check Combo System (2012), 37 descendants of its own
- K141929: Accu-Chek Connect Diabetes Management App (2015), 33 descendants of its own
- K150910: ACCU-CHEK Connect Diabetes Management App (2015), 32 descendants of its own
- K160629: InPen (2016), 21 descendants of its own
- K190487: InPen Dose Calculator (2020), 10 descendants of its own

## Recalls of this device
- Apr 30, 2009 · Not classified · Z-1646-2009: The "up" and "down" buttons, which are used for changing the program in the menu or to administer additional insulin through a bolus delivery, may experience intermittent failure or completely cease t

## Indications for use
The ACCU-CHEK Spirit Insulin Infusion Pump is intended for the subcutaneous continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin as prescribed by a physician. The ACCU-CHEK Insulin Pump Configuration Software facilitates the monitoring and programming of the pump settings.

Source page: https://510kreport.com/device/K060876
Methodology: https://510kreport.com/methodology