# K110471: Babi Plus Infant Nasal Cannula System

- Pathway: 510(k) (Special)
- Applicant: A Plus Medical
- Decided: Oct 7, 2011 after 231 days
- Product code: BZD (Ventilator, Non-Continuous (Respirator))
- Device class: 2
- Regulation: 21 CFR 868.5905
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K871157 (1987). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093716: Babi Plus Infant Nasal Cannula System, A Plus Medical (2010) Summary page 1.

## Most influential descendants
- K121379: Pneuton Mini Ventilator Pneuton Mini Non-Invasive Ventilation (Niv) Kit Accessory (2012), 0 descendants of its own

## Indications for use
Single patient use device intended for use with neonates, infants and children under 10 Kg requiring a nasal prong interface during intermittent or continuous gas flow therapy in the hospital critical care unit.

Source page: https://510kreport.com/device/K110471
Methodology: https://510kreport.com/methodology