# K203711: IWL2020 Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diabetes Care, Inc.
- Decided: May 6, 2022 after 501 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
Longest line of descent: 7 generations back to K010362 (2001). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160944: ACCU-CHEK Guide Blood Glucose Monitoring System, Roche Diabetes Care, Inc. (2016) Summary page 4.

## Indications for use
The IWL2020 Blood Glucose Monitoring System is comprised of the IWL2020 meter and IWL2020 test strips. The IWL2020 Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip as an aid in monitoring the effectiveness of glucose control. The IWL2020 Blood Glucose Monitoring System is intended for in vitro diagnostic single patient use by people with diabetes at home. The IWL2020 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. This system is not for use in diagnosis or screening of diabetes mellitus, nor for neonatal use.

Source page: https://510kreport.com/device/K203711
Methodology: https://510kreport.com/methodology