# K992323: Datex-Ohmeda Cardiocap 5, F-MX, F-MXG and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Datex-Ohmeda, Inc.
- Decided: Nov 1, 1999 after 112 days
- Product code: MLD (Monitor, St Segment With Alarm)
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
1 of 5 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K093881: Trusignal SPO2 Finger Sensor, Trusignal SPO2 Ear Sensor, Trusignal SPO2 Wrap Sensor (2010), 2 descendants of its own
- K250931: Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U103-117); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U410-121); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U110-121) (2025), 0 descendants of its own
- K132696: Trusignal SPO2 Adult and Pediatric Adhesive Wrap Disposable Sensor (2013), 0 descendants of its own
- K012837: Modification to: Datex-Ohmeda Cardiocap 5 (Rev B) and Accessories (2001), 0 descendants of its own

## Recalls of this device
- Oct 17, 2003 · Not classified · Z-0143-04: Datex-Ohmeda Cardiocap/5 Patient Monitors have bracket pins which do not adequately secure them to their optional mounting stand so the monitors may fall.

## Indications for use
The Datex-Ohmeda Cardiocap 5 (Models F-MX, F-MXG) and accessories is indicated for indoor monitoring of hemodynamic (ECG, Impedance respiration, NIBP, Temperature, SPO2 and invasive pressure), respiratory (CO2, 02, N20, respiration rate, anesthetic agent and agent identification), ventilatory (airway pressure, volume and flow) and relaxation status (NMT) of all huspital patients. Impedance Respiration measurement is indicated for patients ages 3 and up. Cardiocap 5 is indicated for patients with weight from 5 kg (11 1b.) up. The monitor is indicated for usc by qualified medical personnel! only.

Source page: https://510kreport.com/device/K992323
Methodology: https://510kreport.com/methodology