# K143603: Darlinghurst Vented, Darlinghurst NV-AAV

- Pathway: 510(k) (Traditional)
- Applicant: Resmed, Ltd.
- Decided: May 21, 2015 after 154 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: 5 generations back to K936047 (1995). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071149: Hri 6500, 6600 and 6700 Series V2MASKS, Hans Rudolph, Inc. (2008) Summary page 5.

## Indications for use
The Darlinghurst Vented mask is a non-invasive accessory used for channeling airflow to a patient from positive airway pressure (PAP) devices. The mask is: • to be used on patients weighing >66 lb (30 kg), for whom non-invasive positive airway pressure therapy has been prescribed • disposable devices, intended for short-term treatment (up to 7 days) of a single patient, in the hospital environment only. The Darlinghurst NV-AAV mask is a non-invasive accessory used for channeling airflow to a patient from a positive airway pressure (PAP) device. The mask is: • to be used on patients weighing >66 lb (30 kg), for whom non-invasive positive airway pressure therapy has been prescribed • a disposable device, intended for short-term treatment (up to 7 days) of a single patient, in the hospital environment only • intended to be used with breathing circuits or positive pressure ventilation (PPV) devices that provide their own method of venting expired or supplemental gases.

Source page: https://510kreport.com/device/K143603
Methodology: https://510kreport.com/methodology