# K032308: Blood Pressure Monitor, Model M100

- Pathway: 510(k) (Traditional)
- Applicant: Meditek Technology, Inc.
- Decided: Nov 10, 2003 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: 1 generation back to K990807 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990807: HL148 & HL168, Health & Life Co., Ltd. (1999) Summary page 1.

## Indications for use
The M100 of blood pressure monitor is an electronic device that provides a signal from which the systolic, diastolic and rate of heart beats can be derived through the use of transducers placed on the surface of the body. The signals of measurement can be stored in the memory of device, and then can be displayed on the screen of device and/or be transmitted out of device by using the standard signal transmission cable.

Source page: https://510kreport.com/device/K032308
Methodology: https://510kreport.com/methodology