# K181070: iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+)

- Pathway: 510(k) (Traditional)
- Applicant: Andon Health Co, Ltd.
- Decided: Feb 1, 2019 after 284 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: 8 generations back to K024194 (2003). 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)
- K170231: iHealth Align Gluco-Monitoring System (BG1); iHealth Wireless Smart Gluco-Monitoring System (BG5), Andon Health Co, Ltd. (2017) Summary page 4.

## Indications for use
The iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+) consists of the iHealth Wireless Smart Glucose Meter (BG5S) and the iHealth Blood Glucose Test Strips (EGS-2003). The iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+) is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf, or thigh. The iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+) is intended to be used by a single person and should not be shared. The iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+) is intended for 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. The iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+) should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

Source page: https://510kreport.com/device/K181070
Methodology: https://510kreport.com/methodology