# K090804: Nasal Aire II Pediatric, Model 5 Sizes, Model TBD

- Pathway: 510(k) (Traditional)
- Applicant: Innomed Technologies, Inc./Respcare, Inc.
- Decided: Nov 5, 2009 after 225 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 K900164 (1990). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060105: Vpap Iii ST-a/Kidsta Mask System, Resmed, Ltd. (2006) Summary page 1.
- K022465: Modification to Nasal-Aire, Innomed Technologies (2003) Summary page 1.
- K002001: Breeze Sleepgear with Dreamseal, Puritan Bennett Corp. (2000) Summary page 1.
- K072993: Reusable Headrest with Nasal Seal, Aeiomed, Inc. (2008) Summary page 1.
- (no number) Infant Nasal CPAP Set: named in the summary without a submission number

## Indications for use
The Nasal-Aire II Pediatric interface is an accessory to positive pressure ventilation devices (i.e. CPAP, Bi-Level) for both adult and pediatric patients aged seven and older or weighing more than 40 lbs, in the hospital, clinic or home environments. The Nasal-Aire II Pediatric is intended for single-patient re-use in the home environment and multiple-patient re-use in the hospital / institutional environment.

Source page: https://510kreport.com/device/K090804
Methodology: https://510kreport.com/methodology