# K051149: Meditech Model Abpm-04

- Pathway: 510(k) (Traditional)
- Applicant: Meditech Kft.
- Decided: Nov 18, 2005 after 198 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Meditech ABPM-04 device automatically measures the systolic and diastolic arterial blood pressure and the pulse rate of adult patients under ambulatory circumstances using the standard oscillometric method with a standard upper arm cuff, sequentially as pre-programmed by the adjoining software. The device is intended for use with the standard indications and contraindications for ambulatory blood pressure monitoring.

Source page: https://510kreport.com/device/K051149
Methodology: https://510kreport.com/methodology