# K093716: Babi Plus Infant Nasal Cannula System

- Pathway: 510(k) (Traditional)
- Applicant: A Plus Medical
- Decided: May 13, 2010 after 162 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: 1 generation back to K871157 (1987). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
1 of 5 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K871157: C.P.a.P. Nasal Cannula, Hudson Oxygen Therapy Sales Co. (1987) Summary page 1.

## Most influential descendants
- K110471: Babi Plus Infant Nasal Cannula System (2011), 1 descendant of its own
- K121379: Pneuton Mini Ventilator Pneuton Mini Non-Invasive Ventilation (Niv) Kit Accessory (2012), 0 descendants of its own
- K110383: Babi*Plus Pressure Relief Manifold - 10CM H20, 12.5CM H20, 15CM H20 (2011), 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/K093716
Methodology: https://510kreport.com/methodology