# K030563: Arabella Ncpap Masks

- Pathway: 510(k) (Traditional)
- Applicant: Hamilton Medical AG
- Decided: Sep 9, 2003 after 200 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 K945740 (1995). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984254: Infant Flow Ncpap Masks, Sensor Medics Corp. (1999) Summary page 2.
- K011516: Infant Flow System, Model M672P, Eme (Electro Medical Equipment), Ltd. (2001) Summary page 2.

## Indications for use
The Hamilton Medical ARABELLA’ NCPAP Masks (single patient use only) are intended for use with the Hamilton ARABELLA’ infant nasal CPAP system which consists of (a.) the tubing and support set and (b.) the monitoring oxygen/air mixer, This system is intended to provide CPAP therapy with a nasal mask or nasal prongs in hospitals or other clinical settings to treat newborns and infants.

Source page: https://510kreport.com/device/K030563
Methodology: https://510kreport.com/methodology