# K012837: Modification to: Datex-Ohmeda Cardiocap 5 (Rev B) and Accessories

- Pathway: 510(k) (Special)
- Applicant: Datex-Ohmeda
- Decided: Sep 14, 2001 after 22 days
- Product code: MLD (Monitor, St Segment With Alarm)
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K992323 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992323: Datex-Ohmeda Cardiocap 5, F-MX, F-MXG and Accessories, Datex-Ohmeda, Inc. (1999) Summary page 2.

## 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.
- Sep 16, 2002 · Not classified · Z-0611-03: Falsely high blood oxygen saturation readings in some circumstances which could result in no alarm in a critical life-threatening situation.

## Indications for use
The Datex-Ohmeda Cardiocap 5 (REV. B) and accessories are 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 hospital patients. With the N-XOSAT option, monitoring of arterial oxygen saturation includes monitoring hospital patients under clinical motion conditions. Impedance Respiration measurement is indicated for patients ages 3 years and older. Cardiocap/5 is indicated for patients weighing 5 kg (11 Ib.) or more. The monitor is indicated for use by qualified medical personnel only.

Source page: https://510kreport.com/device/K012837
Methodology: https://510kreport.com/methodology