# K143700: CPAP Cannulaide

- Pathway: 510(k) (Traditional)
- Applicant: Salter Labs
- Decided: Aug 5, 2015 after 224 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: 3 generations back to K902859 (1991). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100011: Fisher & Paykel Healthcare Bubble Cpap System, Fisher & Paykel Healthcare, Ltd. (2010) Summary page 4.

## Indications for use
CPAP Cannulaide is indicated to aid in securing and positioning the nasal interface for neonates and infants undergoing non-invasive ventilation in an acute care setting. CPAP Cannulaide is a disposable device and is for single patient use only.

Source page: https://510kreport.com/device/K143700
Methodology: https://510kreport.com/methodology