# K022465: Modification to Nasal-Aire

- Pathway: 510(k) (Traditional)
- Applicant: Innomed Technologies
- Decided: Mar 21, 2003 after 238 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
No predicates in its family tree.
19 later devices descend from it; 8 cite it directly.
1 of 20 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K042130: Aura Cpap Patient Interface (2004), 8 descendants of its own
- K100121: Model 300157 Cpap System (2010), 5 descendants of its own
- K031883: Lyra Nasal Mask (2003), 3 descendants of its own
- K140980: TI Nasal Mask (2015), 2 descendants of its own
- K210844: DreamWear Silicone Pillows Mask (2021), 1 descendant of its own

## Indications for use
The Nasal-Aire II™ Interface is an accessory to positive pressure ventilation devices for patients suffering from Obstructive Sleep Apnea requiring positive pressure breathing therapy (i.e. CPAP, BiLevel)

Source page: https://510kreport.com/device/K022465
Methodology: https://510kreport.com/methodology