# K080853: Duo-Care Blood Glucose and Blood Pressure Monitor System

- Pathway: 510(k) (Abbreviated)
- Applicant: Genexel-Sein, Inc.
- Decided: Feb 20, 2009 after 331 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: 4 generations back to K021239 (2002). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052108: Sein Blood Glucose and Blood Pressure Monitor System, Model BGP-100, Sein Electronics Co., Ltd. (2005) Summary page 1.

## Indications for use
The DUO-CARE blood glucose and blood pressure measurement system consists of a meter with wrist cuff and test strips. The system is intended for use in the quantitative measurement of glucose in whole blood taken from the fingertip. Testing is done outside the body (in Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes mellitus, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. It is not intended for use on neonates. Also the system measures systolic and diastolic blood pressure and pulse rate from adult's wrist in the home care environment. The device employs a wrist cuff and the oscillometric method of measurement. The system includes optional accessory software that is installed on the users' computers for data management purposes.

Source page: https://510kreport.com/device/K080853
Methodology: https://510kreport.com/methodology