# K042887: Accu-Chek Spirit

- Pathway: 510(k) (Traditional)
- Applicant: Disetronic Medical Systems AG
- Decided: Mar 18, 2005 after 150 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: 1 generation back to K031390 (2003). 2 ancestors in all.
39 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)
- K031390: Medtronic Minimed Paradigm Insulin Pump, Model MMT-712, Minimed, Inc. (2003)
- K032257: Model IR 1200 Insulin Pump, Animas Corp. (2003) Summary page 1.

## Most influential descendants
- K060876: Accu-Chek Insulin Pump Configuration Software (Standard), Model 04625137001; Accu-Chek Insulin Pump Configuration Softwa (2006), 38 descendants of its own
- 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

## Recalls of this device
- Apr 22, 2015 · Class II · Z-1734-2015: Roche has become aware of an increase of mechanical errors experienced by customers using the Accu-Chek Spirit Combo insulin infusion pump and Accu-Chek Spirit insulin infusion pump when the insulin p

## 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.

Source page: https://510kreport.com/device/K042887
Methodology: https://510kreport.com/methodology