# K060705: Carina Home

- Pathway: 510(k) (Traditional)
- Applicant: Draeger Medical B.V.
- Decided: Jun 14, 2006 after 90 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K902859 (1991). 54 ancestors in all.
22 later devices descend from it; 2 cite it directly.
9 of 77 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052554: Modification to: Ivent 201 Portable Ventilator, Versamed Medical Systems, Inc. (2005) Summary page 2.
- K040790: Modification to LTV 1000 Ventilator/Breathing Circuits, Pulmonetic Systems, Inc. (2004) Summary page 2.
- K033008: Air Safety Hepa and Non-Hepa Filters, Air Safety, Ltd. (2004) Summary page 2.
- K003068: Savina, Drager Medizintechnik GmbH (2001) Summary page 2.
- K970839: Servo Ventilator 300A, Siemens Elema AB (1997) Summary page 2.

## Most influential descendants
- K103167: Stellar 150 (2011), 20 descendants of its own
- K113053: Bipap a 30 Ventilatory Support System (2012), 8 descendants of its own
- K113288: Vpap ST-a (2012), 7 descendants of its own
- K121623: Bipap a 40 Ventilatory Support System (2012), 6 descendants of its own
- K181166: Trilogy Evo (2019), 5 descendants of its own

## Recalls of this device
- Jan 21, 2009 · Not classified · Z-1263-2009: The device may not generate a pilot line disconnect alarm if the pilot line becomes disconnected, which may potentially result in a substantial reduction in tidal volume delivery.

## Indications for use
the Carina home is a pressure controlled and volume controlled (pressure regulated) ventilator. The device is intended for use with patients with a tidal volume of 100 mL upwards. It is used for patients with respiratory insufficiency, using room air (also with additional oxygen). Federal law restricts this device to sale by or on the order of a physician.

Source page: https://510kreport.com/device/K060705
Methodology: https://510kreport.com/methodology