# K200277: Livongo Blood Glucose Monitoring System (BG1000)

- Pathway: 510(k) (Traditional)
- Applicant: Livongo Health, Inc.
- Decided: Jun 4, 2020 after 121 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: 4 generations back to K002134 (2000). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181527: On Call Sure Blood Glucose Monitoring System, On Call Sure Sync Blood Glucose Monitoring System, ACON Laboratories, Inc. (2018) Summary page 4.

## Indications for use
The Livongo Blood Glucose Monitoring System (BG1000) is composed of the Livongo Blood Glucose Meter (BG1000) and Livongo Blood Glucose Test Strips (BG1000). The system is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood from the fingertips. The system is intended for self-testing by people with diabetes at home as an aid to monitor the effectiveness of diabetes control programs. The Livongo Blood Glucose Monitoring System (BG1000) is intended for single-patient use and should not be shared. The system is for in vitro diagnostic use and is not intended for the diagnosis of or screening for diabetes, nor intended for use on neonates.

Source page: https://510kreport.com/device/K200277
Methodology: https://510kreport.com/methodology