# K043551: Datex-Ohmeda S/5 PSM Module, (Consisting of E-PSM and E-PSMP Modules) and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Datex-Ohmeda
- Decided: Feb 18, 2005 after 57 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: 1 generation back to K041772 (2004). 1 ancestor in all.
15 later devices descend from it; 1 cites it directly.
2 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041772: Datex-Ohmeda Prestn.01 Module (Model Family M-Prestn.01) and Accessories, Datex-Ohmeda (2004) Summary page 2.

## Most influential descendants
- K062576: Datex-Ohmeda S/5 E-PSM (P) Module (Consisting of E-PSM, E-PSMP and E-Intpsm Modules) and Accessories (2006), 14 descendants of its own
- K120598: Procare Monitor B40 (2012), 10 descendants of its own
- K130584: Monitor B40 (2013), 8 descendants of its own
- K133576: Monitor B40 (2014), 7 descendants of its own
- K151063: Monitor B40 (2015), 5 descendants of its own

## Indications for use
The Datex-Ohmeda S/5 PSM module (consisting of E-PSM and E-PSMP modules) 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, SpO₂ (including monitoring during conditions of clinical patient motion), and invasive blood pressure. Impedance Respiration measurement is indicated for patients ages 3 and up. The NIBP measurement is indicated for patients who weigh 5kg (11 lb.) and up. The device is indicated for use by qualified medical personnel only.

Source page: https://510kreport.com/device/K043551
Methodology: https://510kreport.com/methodology