# K171822: NuvoMed Wireless Blood Glucose Monitoring System (Model BGM-6/0352)

- Pathway: 510(k) (Special)
- Applicant: Biotest Medical Corporation
- Decided: Sep 20, 2017 after 93 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: 2 generations back to K070585 (2007). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141351: Supercheck Plus Blood Glucose Monitoring System, Super Check Plus Multi Blood Glucose Monitoring System, Biotest Medical Corp. (2015) Summary page 4.

## Indications for use
NuvoMed Wireless Blood Glucose Monitoring System (Model BGM-6/0352) The NuvoMed Wireless Blood Glucose Monitoring System (Model BGM-6/0352) consists of the NuvoMed Wireless Blood Glucose Monitor and the NuvoMed Blood Glucose Test Strip. The NuvoMed Wireless Blood Glucose Monitoring System (Model BGM-6/0352) is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips or forearm. The NuvoMed Wireless Blood Glucose Monitoring System (Model BGM-6/0352) is intended to be used by a single person and should not be shared. The NuvoMed Wireless Blood Glucose Monitoring System (Model BGM-6/0352) is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid in monitoring the effectiveness of a diabetes control program. The NuvoMed Wireless Blood Glucose Monitoring System (Model BGM-6/0352) 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/K171822
Methodology: https://510kreport.com/methodology