# K103410: Neopap System

- Pathway: 510(k) (Traditional)
- Applicant: Childrens Medical Ventures, LLC
- Decided: Mar 30, 2011 after 128 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 K000401 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040862: Guardian Neonate Cpap/Humidification System, Caradyne, Ltd. (2004) Summary page 1.

## Indications for use
The NeoPAP System is intended to provide continuous positive airway pressure (CPAP) for use in hospitals to treat newborns and infants, weighing less than 5 kg, with RDS or who are recovering from RDS. (Respiratory Distress Syndrome).

Source page: https://510kreport.com/device/K103410
Methodology: https://510kreport.com/methodology