# K840865: Infant Star Ventilator

- Pathway: 510(k) (Traditional)
- Applicant: Infrasonics Corp.
- Decided: Apr 30, 1984 after 63 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.
23 later devices descend from it; 1 cites it directly.
9 of 24 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
- K031745: Infant Flow Plus Infant Cpap System with Sipap Function (2004), 22 descendants of its own
- K062093: Avea Ventilator (2006), 21 descendants of its own
- K081521: Modification to Hamilton-G5 (2008), 16 descendants of its own
- K102775: Hamilton-C2 (2011), 14 descendants of its own
- K112006: Hamilton-TC1 (2012), 13 descendants of its own

Source page: https://510kreport.com/device/K840865
Methodology: https://510kreport.com/methodology