# K041169: Piesometer, Model MK-1

- Pathway: 510(k) (Traditional)
- Applicant: Canamet Canadian Natl Medical Technologies, Inc.
- Decided: Aug 24, 2004 after 112 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 K855127 (1986). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031479: Ambulatory Blood Pressure (Abp) 92506 Report Management System (RMS), Model 92506, Datex-Ohmeda, Inc. (2003) Summary page 1.
- K941167: Non-Invasive Blood Pressure (Nibp) Monitor (Model 90553), Spacelabs Medical, Inc. (1994) Summary page 1.
- K904318: Local Report Generator, Spacelabs, Inc. (1990) Summary page 1.
- K855127: Ambulatory Blood Pressure Monitor Spacelabs #90202, Spacelabs, Inc. (1986) Summary page 1.
- K913844: Accutracker DX, Suntech Medical Instruments, Inc. (1992) Summary page 1.

## Indications for use
The device is used to provide data to qualified medical personnel or trained users for the purpose of assessing the patient's cardiac health via blood pressure readings taken during daily activity for up to a 48-hour period. Measurements of systolic, diastolic, and heart rate are made and stored. The device can also be used to provide blood pressure and heart rate data in single measurement mode. The device is also intended to provide preliminary blood pressure data from ambulatory patients for non-time critical applications only. It is for use in hospitals, clinics or physicians offices by a qualified physician or trained staff member under the supervision of that physician. It is also intended for home care use by a trained patient with periodic health consultations from his or her physician. Patient diagnosis is not to be performed solely based on the results of this device.

Source page: https://510kreport.com/device/K041169
Methodology: https://510kreport.com/methodology