# K072885: Carina System, Model 8419350; Carina Basic Device, Model 5704110

- Pathway: 510(k) (Traditional)
- Applicant: Draeger Medical AG & Co. KG
- Decided: Apr 7, 2008 after 181 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 2 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K902859 (1991). 67 ancestors in all.
No later device cites it as a predicate yet.
4 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984056: LTV 1000, Pulmonetic Systems, Inc. (1999) Summary page 2.
- K060705: Carina Home, Draeger Medical B.V. (2006) Summary page 2.
- K982454: Bipap Vision Ventilatory Support, Respironics, Inc. (1998) Summary page 2.

## Recalls of this device
- Jul 12, 2023 · Class I · Z-2248-2023: Presence of polyether polyurethane (PE-PUR) and emission of 1,3-Dichloropropan-2-ol that exceed the acceptable uptake level during continuous use (>30 days) in pediatric patients.
- Apr 26, 2018 · Class II · Z-1954-2018: The valve assembly material may become corroded due to insufficient cleaning by a supplier. There is a risk of the breathing gas becoming contaminated in the affected devices.

## Indications for use
The Carina is a long-term ventilator for ventilator-dependent patients or ventilator-assisted patients. The device is intended for treatment of sub-acute care patients in hospital or medical rooms. The device is intended for invasive ventilation or non-invasive ventilation. The device is intended for patients with a tidal volume of at least 100 mL. The device is intended for use by qualified medical personnel.

Source page: https://510kreport.com/device/K072885
Methodology: https://510kreport.com/methodology