# K213867: Carestation 750/750c

- Pathway: 510(k) (Traditional)
- Applicant: Datex-Ohmeda, Inc.
- Decided: Mar 28, 2023 after 473 days
- Product code: BSZ (Gas-Machine, Anesthesia)
- Device class: 2
- Regulation: 21 CFR 868.5160
- Recalls of this device: 4 (4 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K902859 (1991). 87 ancestors in all.
No later device cites it as a predicate yet.
10 of 88 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151570: Carestation 620/650/650C, Datex-Ohmeda, Inc. (2016) Summary page 4.

## Recalls of this device
- Nov 14, 2025 · Class I · Z-0914-2026: Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC mains power is unplugged or in the event of an AC mains power f
- Nov 14, 2025 · Class I · Z-0915-2026: Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC mains power is unplugged or in the event of an AC mains power f
- Mar 21, 2025 · Class I · Z-1637-2025: GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these 
- Mar 21, 2025 · Class I · Z-1635-2025: GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these 

## Indications for use
The Carestation750/750c anesthesia systems are intended to provide monitored anesthesia care, general inhalation anesthesia and/ or ventilatory support to a wide range of patients (neonatal, pediatric, and adult). The anesthesia systems are suitable for use in a patient environment, such as hospitals, surgical centers, or clinics. The systems are intended to be operated by a clinician qualified in the administration of general anesthesia.

Source page: https://510kreport.com/device/K213867
Methodology: https://510kreport.com/methodology