# K041491: Zewa MFM-007 Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Zewa, Inc.
- Decided: Sep 20, 2004 after 108 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: 2 generations back to K952826 (1996). 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)
- K992328: Fuzzy Automatic Blood Pressure Monitor Models MD-750, MD-770, MD-800, Meditec Co., Ltd. (1999) Summary page 1.

## Indications for use
The Zewa MFM-007 Blood Pressure Monitor is intended for use by adults with moderately active to inactive lifestyles for measuring the systolic and diastolic blood pressure, and pulse rate (heart rate) by using an inflated cuff which is wrapped around the upper arm.

Source page: https://510kreport.com/device/K041491
Methodology: https://510kreport.com/methodology