# K123935: Ihealth BG5/BG5L Wireless Smart Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Andon Medical Co., Ltd.
- Decided: Apr 12, 2013 after 113 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: 5 generations back to K024194 (2003). 5 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120813: Blood Glucose Monitoring System, Andon Medical Co., Ltd. (2012) Summary page 2.
- K110017: AG-608N Blood Glucose Monitoring System, Andon Medical Co., Ltd. (2012) Summary page 4.

## Most influential descendants
- K153278: Wireless Smart Gluco-Monitoring System (2016), 2 descendants of its own
- K170231: iHealth Align Gluco-Monitoring System (BG1); iHealth Wireless Smart Gluco-Monitoring System (BG5) (2017), 1 descendant of its own
- K181070: iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+) (2019), 0 descendants of its own

## Indications for use
Health BG5 wireless Smart Gluco-Monitoring System is intended to be used for: * quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf or thigh * single person measurement only and should not be shared * self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control Health 8G5 wireless Smart Gluco-Monitoring System should not be used for the diagnosis of or screening for diabetes, or for neonatal use. Alternative Site Testing (AST) should be done only during steady state times when glucose levels are not changing rapidly. The AGS1 0001 test strips are intended for use with the iHealth 8G5 meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf or thigh using the iHealth BG5 meter. The iHealth control solutions are intended for use with the iHealth BG5 Blood Glucose Monitoring System, to check that the glucose meter and test strips are working properly. These solutions contain a known range of glucose, as indicated on the bottles. The iHealth Gluco-Smart App is an iOS app for iPhone, iTouch, and iPad and is used for data extraction and analysis in iHealth BG5 and BG5L Wireless Smart Gluco-Monitoring System. Health BG5L wireless Smart Gluco-Monitoring System is intended to be used for: * quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf or thigh * single person measurement only and should not be shared * self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control Health BG5L wireless Smart Gluco-Monitoring System should not be used for the diagnosis of or screening for diabetes, or for neonatal use. Alternative Site Testing (AST) should be done only during steady state times when glucose levels are not changing rapidly. The AGS 1000I test strips are intended for use with the iHealth BG5 meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf or thigh using the iHealth BG5L meter. The iHealth control solutions are intended for use with the iHealth BG5L Blood Glucose Monitoring System, to check that the glucose meter and test strips are working properly. These solutions contain a known range of glucose, as indicated on the bottles. The iHealth Gluco-Smart App isan iOS app for iPhone, iTouch, and iPad and is used for data extraction and analysis in iHealth BG5 and BG5L Wireless Smart Gluco-Monitoring System.

Source page: https://510kreport.com/device/K123935
Methodology: https://510kreport.com/methodology