# K080636: Duo-Max Blood Pressure & Glucose Monitor HMF-100

- Pathway: 510(k) (Traditional)
- Applicant: Hubdic Co., Ltd.
- Decided: Feb 13, 2009 after 344 days
- Product code: CGA (Glucose Oxidase, Glucose)
- 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). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 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.
- K051285: Glucolab Blood Glucose Monitoring System, Infopia Co, Ltd. (2005) Summary page 1.

## Indications for use
The Blood pressure and glucose monitor, Duo-MaxTM consists'of a meter with wrist cuff and glucose test strips. The glucose test system is intended for use in the quantitative measurement of glucose in capillary whobl blood taken from.the fingertip, dorsal hand, ventral palm, upper arm, forearn, calf and thigh. Glucose testing is- done outside the body (In Vitro diabetes mellitus, or in clinical settings by healthcare professionals. Glucose testing system is not to be used for the diagnosis or screening of diabetes. It is not intended for use on neonates. Also the blood pressure test 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 oscillomentric metric method of measurement.

Source page: https://510kreport.com/device/K080636
Methodology: https://510kreport.com/methodology