# K202885: GlucoSure HT Plus Blood Glucose Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Apex BioTechnology Corp.
- Decided: Sep 15, 2021 after 352 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). 8 ancestors in all.
1 later device descends 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)
- K170267: BGM009 Plus Blood Glucose Monitoring System, Apex BioTechnology Corp. (2017) Summary page 4.

## Most influential descendants
- K220421: BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring System (2022), 0 descendants of its own

## Indications for use
GlucoSure HT Plus Blood Glucose Monitoring System is intended to quantitatively measure blood glucose in fresh capillary whole blood drawn from fmgertips, palm, or foreatm. Altelnative site testing for glucose test should be perfOlmed 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 mellitus 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 intended for diagnosis or screening of diabetes or for neonatal use. The GlucoSure HT Blood Glucose Test Strips are to be used with the GlucoSureHT Plus Blood Glucose Meter to quantitatively measure glucose in capillaly whole blood taken from fmgertips, palm, or foreal"m.

Source page: https://510kreport.com/device/K202885
Methodology: https://510kreport.com/methodology