# K031781: Datex-Ohmeda Prestn Module, (Model Family M-Prestn) and Accessories

- Pathway: 510(k) (Special)
- Applicant: Datex-Ohmeda
- Decided: Jun 25, 2003 after 15 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- 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 K010463 (2001). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993608: Datex-Ohmeda NE12STPR Module (Model Family M-NE12STPR), Datex-Ohmeda, Inc. (2000) Summary page 2.
- K011670: Datex-Ohmeda Oxygen Saturation Module, M-Osat and Accessories (with Trutrak+Motion Correction Performance, Datex-Ohmeda (2001)

## Indications for use
The Datex-Ohmeda PRESTN module (model family M-PRESTN) and accessories are indicated for monitoring of hemodynamic parameters of all hospital patients. The hemodynamic parameters of the module comprise ECG including ST-segment and arrhythmia, Impedance respiration, NIBP, Temperature, Sp02 (including monitoring during conditions of clinical patient motion), and invasive blood pressure. Impedance Respiration measurement is indicated for patients aged 3 and up. The NIBP measurement is indicated for patients who weigh 5kg (11lb.) and up. The device is indicated for use by quahfied medical personnel only.

Source page: https://510kreport.com/device/K031781
Methodology: https://510kreport.com/methodology