# K903089: Babylog 8000 Infant Ventilator

- Pathway: 510(k) (Traditional)
- Applicant: Drager, Inc.
- Decided: Jun 10, 1991 after 332 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
No predicates in its family tree.
11 later devices descend from it; 1 cites it directly.
6 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K093632: Infinity Acute Care System Workstation Neonatal Care (2010), 10 descendants of its own
- K121225: Hamilton-C2 (2012), 8 descendants of its own
- K123637: Hamilton-C3 (2012), 4 descendants of its own
- K161450: Hamilton-C3 (2017), 3 descendants of its own
- K140939: Hamilton-T1,Hamilton-C1 (2015), 2 descendants of its own

Source page: https://510kreport.com/device/K903089
Methodology: https://510kreport.com/methodology