# K050413: Amplief Wrist Blood Pressure Monitor, Model M600

- Pathway: 510(k) (Traditional)
- Applicant: Amplife Corporation
- Decided: Mar 4, 2005 after 14 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 K021305 (2002). 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)
- K040002: Microlife Wrist Watch Blood Pressure Monitor, Model BP3AX1, Microlife Intellectual Property Gmb (2004) Summary page 1.

## Indications for use
The AMPLIFE Wrist Watch Blood Pressure Monitor, Model M600 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 wrist.

Source page: https://510kreport.com/device/K050413
Methodology: https://510kreport.com/methodology