# K222207: Babylog VN800, Babylog VN600

- Pathway: 510(k) (Traditional)
- Applicant: Draegerwerk AG & CO Kgaa
- Decided: May 16, 2023 after 295 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K902859 (1991). 32 ancestors in all.
No later device cites it as a predicate yet.
4 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093632: Infinity Acute Care System Workstation Neonatal Care, Drager Medical AG & Co. Kgaa (2010) Summary page 4.

## Indications for use
The Babylog intensive care Ventilator (Babylog VN800 / Babylog VN600) is intended for the ventilation of neonates with a body weight of 0.4 kg (0.88 lb) to 10 kg (22 lb) and for pediatric patients with an IBW of 5.2 kg (11.5 lb) to 20.1 kg (44.3 lb). This device provides mandatory pressure-controlled ventilation modes, ventilation modes for supporting spontaneous breathing, and ventilation monitoring.

Source page: https://510kreport.com/device/K222207
Methodology: https://510kreport.com/methodology