# K182992: BGM014 Blood Glucose Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Apex BioTechnology Corp.
- Decided: Nov 28, 2018 after 30 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 K011233 (2001). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161299: BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring System, Apex BioTechnology Corp. (2016) Summary page 4.

## Indications for use
The BGMO014 Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alternative site testing should be performed only during steady-state (when glucose is not changing rapidly). Testing is done outside the body (In Vitro diagnostic use). It is intended for self-testing by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It should only be used by a single patient and it should not be shared. It is not indicated for the diagnosis of or screening for diabetes or for neonatal use. The BGMO014 Blood Glucose Monitoring System is comprised of the BGM014 Blood Glucose Meter and BGM014 Blood Glucose Test Strip.

Source page: https://510kreport.com/device/K182992
Methodology: https://510kreport.com/methodology