# K130621: Broadmaster Healthcare System

- Pathway: 510(k) (Traditional)
- Applicant: Broadmaster Biotech Corporation
- Decided: Jul 30, 2013 after 144 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 K001907 (2000). 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)
- K070941: Clever Chek Health Care System Software, Version 1.0, Taidoc Technology Corporation (2007) Summary page 1.

## Indications for use
The BroadMaster HealthCare Systemn is a software accessory compatible with legally marketed BroadMaster Biotech glucose meters, Such as the Glucose Shepherd Blood Glucose Monitoring System and ADVOGATEO Redi-Gode* B3MB-EA001 S Blood Glucose Monitoring System and is intended for use in the home setting by people with diabetes. Ftis intended to aid in the review, analysis, and evaluation of patient data to support diabetes management. The BroadMaster HealthCare System receives via USS, stores, and uses patient data for display and reporting, sets meter date, lime and alarm. The software is designed (or multiple users use and only compatible with) personal computer. It's not compatible with other devices such as PDAs or smartphones.

Source page: https://510kreport.com/device/K130621
Methodology: https://510kreport.com/methodology