# K031896: Nasal-Air Critical Care

- Pathway: 510(k) (Traditional)
- Applicant: Innomed Technologies
- Decided: Jan 14, 2004 after 209 days
- Product code: MNS (Ventilator, Continuous, Non-Life-Supporting)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K833786 (1983). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982454: Bipap Vision Ventilatory Support, Respironics, Inc. (1998) Summary page 1.
- K003075: Knightstar 330 Ventilator, Mallinckrodt, Inc. (2001) Summary page 1.
- K022465: Modification to Nasal-Aire, Innomed Technologies (2003) Summary page 1.
- K023244: Mirage Full Face Mask Series 2, Resmed, Ltd. (2002) Summary page 1.

## Indications for use
Nasal-Aire Critical Care ventilator interface is intended for use with a CPAP or Bi-Level device to provide noninvasive ventilation in adult patients for the treatment of respiratory insufficiencies or obstructive sleep apnea. This single use disposable interface is intended for hospital settings.

Source page: https://510kreport.com/device/K031896
Methodology: https://510kreport.com/methodology