# K202534: MTM301 Blood Glucose and Ketone Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Apex BioTechnology Corp.
- Decided: Apr 6, 2022 after 582 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 K945887 (1995). 14 ancestors in all.
No later device cites it as a predicate yet.
1 of 15 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091547: Nova Max Plus Blood Glucose and B-Ketone Monitor System, Nova Max Plus B-Ketone Control Solutions, Nova Max Blood Glucos, Nova Biomedical Corp. (2010) Summary page 4.

## Indications for use
MTM301 Blood Glucose and Ketone Monitoring System: MTM301 Blood Glucose and Ketone Monitoring System is comprised of the MTM301 Blood Glucose and Ketone Meter, the MTM301 Blood Glucose Test Strips, and the MTM301 Blood Ketone test strips. The MTM301 Blood Glucose and Ketone Monitoring System is intended to quantitatively measure blood glucose or blood ketone in fresh capillary whole blood drawn from fingertips. The system 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.

Source page: https://510kreport.com/device/K202534
Methodology: https://510kreport.com/methodology