# K033759: C2 Nasal Mask

- Pathway: 510(k) (Traditional)
- Applicant: Respironics, Inc.
- Decided: Feb 19, 2004 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: 2 generations back to K900164 (1990). 2 ancestors in all.
9 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020641: Spiritus (TM) Respiratory System #SRS 001, Worldwide Medical Technologies, LLC (2002) Summary page 1.

## 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
- K132127: Transcend Auto (2013), 1 descendant of its own
- K121374: ZI Blower (2013), 1 descendant of its own
- K072993: Reusable Headrest with Nasal Seal (2008), 1 descendant of its own

## Indications for use
The C2 Nasal Mask is intended to provide an interface for application of prescribed CPAP or Bi-level therapy. The mask is reusable and for single patient use only. It is intended for adult patients in a home or hospital/institutional environment.

Source page: https://510kreport.com/device/K033759
Methodology: https://510kreport.com/methodology