# K081924: Calhealth, Inc., Finger Blood Pressure Monitor, Mdmouse

- Pathway: 510(k) (Traditional)
- Applicant: Calhealth, Inc.
- Decided: Jan 7, 2009 after 184 days
- Product code: DXN (System, Measurement, Blood-Pressure, Non-Invasive)
- Device class: 2
- Regulation: 21 CFR 870.1130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K894563 (1990). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K894563: Omron Digital Blood Pressure Monitor Model HEM814F, Omron Electronics, Inc. (1990) Summary page 1.

## Most influential descendants
- K261061: BP Go (BPP-855) (2026), 0 descendants of its own

## Indications for use
The CalHealth Finger Blood Pressure Monitor, MDMouse is noninvasive blood pressure measurement systems intended to measure the systolic and diastolic blood pressures and pulse rate of an adult individual, over age 18, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the left index finger. The cuff circumference is designed for Left Index Finger circumference: 1.5' - 3.5' (3.7 -8.8 cm) for finger type.

Source page: https://510kreport.com/device/K081924
Methodology: https://510kreport.com/methodology