# K043550: Amplife Upper Arm Blood Pressure Monitor, Model M100

- Pathway: 510(k) (Traditional)
- Applicant: Amplife Corporation
- Decided: Jan 27, 2005 after 35 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. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K097021: Microlife Automatic Blood Pressure Monitor, Model BP-2BHO. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree

## Indications for use
The AMPLIFE Upper Arm Blood Pressure Monitor, Model MQ00, is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm.

Source page: https://510kreport.com/device/K043550
Methodology: https://510kreport.com/methodology