# K170267: BGM009 Plus Blood Glucose Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Apex BioTechnology Corp.
- Decided: Mar 9, 2017 after 41 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: 6 generations back to K011233 (2001). 7 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141036: BGM009 Blood Glucose Monitoring System, Apex BioTechnology Corp. (2015) Summary page 4.

## Most influential descendants
- K202885: GlucoSure HT Plus Blood Glucose Monitoring System (2021), 1 descendant of its own
- K220421: BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring System (2022), 0 descendants of its own

## Indications for use
The BGMO009 Plus 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). It 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 diabetes control and should only be used by a single patient and it should not be shared. It is not indicated for the diagnosis or screening of diabetes or for neonatal use. The BGM009 Blood Glucose Test Strips are to be used with the BGM009 and BGM009 Plus Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm.

Source page: https://510kreport.com/device/K170267
Methodology: https://510kreport.com/methodology