# K062395: Accu-Chek Smart Pix

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: May 9, 2007 after 266 days
- Product code: NBW (System, Test, Blood Glucose, Over The Counter)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
10 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) ACCU-CHEK® Acculink Modem: named in the summary without a submission number

## Most influential descendants
- K080227: Accu-Chek 360 Diabetes Management System (2008), 9 descendants of its own
- 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

## Indications for use
The ACCU-CHEK® Smart Pix enables persons with diabetes or healthcare professionals to send stored data from their compatible ACCU-CHEK blood glucose monitor and/or Disetronic/ACCU-CHEK Insulin infusion pump to a compatible computer as a set of reports or data stream. The ACCU-CHEK Smart Pix is intended to help monitor and clinically manage individuals with diabetes.

Source page: https://510kreport.com/device/K062395
Methodology: https://510kreport.com/methodology