# K080227: Accu-Chek 360 Diabetes Management System

- Pathway: 510(k) (Abbreviated)
- Applicant: Roche Diagnostics Corp.
- Decided: May 15, 2008 after 106 days
- Product code: MRZ (Accessories, Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K001907 (2000). 2 ancestors in all.
9 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001907: Camit Diabetes Management Software, Roche Diagnostics Corp. (2000)
- K062395: Accu-Chek Smart Pix, Roche Diagnostics Corp. (2007) Summary page 1.

## Most influential descendants
- K100066: Diabetesmanager System, Diabetesmanager-RX System Model Version 1.1 (2010), 8 descendants of its own
- K162532: WellDoc BlueStar, WellDoc BlueStar Rx (2017), 5 descendants of its own
- K190013: WellDoc BlueStar (2019), 4 descendants of its own
- K193654: BlueStar Rx (2020), 3 descendants of its own
- K203434: BlueStar Rx (2021), 1 descendant of its own

## Indications for use
The ACCU-CHEK ® 3600 Diabetes Management System is indicated for use by individuals or healthcare professionals in the home or health care facilities to support effective diabetes management. The software also allows for entry of other healthcare parameters with or without diabetes related information, which can be shown in report and graphical format. This device is indicated for professional use and over-the-counter sale.

Source page: https://510kreport.com/device/K080227
Methodology: https://510kreport.com/methodology