# K142679: Carescape R860

- Pathway: 510(k) (Traditional)
- Applicant: Datex-Ohmeda, Inc.
- Decided: Jun 12, 2015 after 266 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 6 (3 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K902859 (1991). 90 ancestors in all.
1 later device descends from it; 1 cites it directly.
9 of 92 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111116: Engstrom Carestation, Engstrom Pro, Models 1505-9000-000, 1505-9003-000, Datex-Ohmeda (2011) Summary page 4.
- K123149: Servo-I Ventilator System, Maquet Critical Care AB (2014) Summary page 4.

## Most influential descendants
- K210384: Carescape R860 (2021), 0 descendants of its own

## Recalls of this device
- Apr 18, 2022 · Class I · Z-1227-2022: Insufficient battery backup power resulting in premature shutdown of the ventilator when not connected to AC mains power supply.
- Apr 18, 2022 · Class I · Z-1226-2022: Insufficient battery backup power resulting in premature shutdown of the ventilator when not connected to AC mains power supply.
- Jul 14, 2020 · Class II · Z-2883-2020: The oxygen sensor for certain CARESCAPE R860 devices has a potential issue that may result in an inaccurate display of FiO2 value from what is being delivered.
- Oct 5, 2018 · Class I · Z-0463-2019: The ventilator Inspiratory Safety Guard (ISG) may disconnect from the breathing circuit pathway. As a result, this could create a loss of ventilation which may lead to inadequate oxygenation for patie
- Jun 28, 2018 · Class II · Z-2738-2018: The Neonatal Flow Sensor Cable may be missing the connector housing exposing the wires in the cable.
- Dec 8, 2017 · Class II · Z-2266-2018: Potential for the display processor to experience an unexpected failure.

## Indications for use
The CARESCAPE R860 ventilator is designed to provide mechanical ventilation or support to neonatal, pediatric, and adult patients weighing 0.25 kg and above. The CARESCAPE R860 ventilator is a microprocessor based, electronically controlled, pneumatically driven ventilator that includes integrated monitoring of FiO2, airway pressure, flow, and volume. Additional respiratory gas monitoring capabilities are supported through the use of optional GE patient monitoring modules. Not all features are available for all patient types or product configurations. The CARESCAPE R860 ventilator is not a pulmonary function calculation device. The system is designed for facility use, including within-facility transport, and should only be used under the orders of a clinician.

Source page: https://510kreport.com/device/K142679
Methodology: https://510kreport.com/methodology