# K042109: Diasys Integra II

- Pathway: 510(k) (Traditional)
- Applicant: Novacor France
- Decided: Mar 9, 2005 after 216 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 K881771 (1989). 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)
- K003004: Oscar 2, Model 222, Suntech Medical Instruments, Inc. (2000) Summary page 1.
- K881771: Sensocor (TM) Diasys, Sensormedix, Inc. (1989) Summary page 1.

## Indications for use
The Diasys Integra Il is a non-invasive Ambulatory Blood Pressure (ABP) recorder. It measures the systolic, diastolic, mean blood pressure (BP) and the heart rate (HR). It measures and records the patient position and the arterial rigidity (QKd) at the time of each BP measurement. The BP measurements can be performed using the oscillometric mode, the auscultatory mode or the ECG-gated auscultatory mode. The procedure can be: * transfert to a computer for further analysis and report printing using the DiasySoft software * printed out directly in a report form by a printer connected to the unit * transfert to a remote computer through a modem connected to the unit

Source page: https://510kreport.com/device/K042109
Methodology: https://510kreport.com/methodology