# K032433: Nasal Jacks Mask

- Pathway: 510(k) (Traditional)
- Applicant: Resmed, Ltd.
- Decided: Oct 24, 2003 after 79 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 K900164 (1990). 2 ancestors in all.
96 later devices descend from it; 2 cite it directly.
10 of 99 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K900164: Airway Delivery & Management (Adam) Nasal Ventila., Puritan Bennett Corp. (1990) Summary page 1.
- K980721: Sullivan Autoset, Resmed, Ltd. (1998) Summary page 1.

## Most influential descendants
- K042403: Mirage Swift (2004), 80 descendants of its own
- K053352: Comfortlite Nasal Mask (2006), 41 descendants of its own
- K063122: Mirage Quattro Full Face Mask (2007), 38 descendants of its own
- K082558: Comfortlite Nasal Mask (2009), 36 descendants of its own
- K072940: Mirage Micro (2007), 26 descendants of its own

## Indications for use
The Nasal Jacks Mask is an accessory to a non-continuous ventilator (respirator), intended for single-patient multiple use for adult patients prescribed continuous positive aiway pressure (CPAP) and bi-level therapy in hospital, clinical, and home environments.

Source page: https://510kreport.com/device/K032433
Methodology: https://510kreport.com/methodology