# K050171: IT Nasal Mask

- Pathway: 510(k) (Traditional)
- Applicant: Innomed Technologies
- Decided: May 4, 2005 after 98 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: 3 generations back to K833786 (1983). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991648: Reusable Contour II Nasal Mask, Respironics, Inc. (1999) Summary page 1.
- K974453: Nasal Interface Model 7910, Healthdyne Technologies, Inc. (1998) Summary page 1.
- K984428: Sullivan Autoset Nasal Cpap System, Resmed, Ltd. (1999) Summary page 1.

## Indications for use
The InnoMed Technologies IT Nasal Mask is intended to be used as a patient interface for currently-marketed CPAP and Bi-Level positive-pressure ventilation devices capable of generating pressures up to 20cm H 20. It is indicated for use in non-critical care applications such as treatment of adult obstructive sleep apnea and ventilatory support during respiratory insufficiency. The InnoMed Technologies IT Nasal Mask is available by prescription, and is intended for single patient use only for adult patients (>30kg) in home or hospital settings.

Source page: https://510kreport.com/device/K050171
Methodology: https://510kreport.com/methodology