# K042130: Aura Cpap Patient Interface

- Pathway: 510(k) (Abbreviated)
- Applicant: Aeiomed, Inc.
- Decided: Sep 8, 2004 after 33 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 K900164 (1990). 4 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022465: Modification to Nasal-Aire, Innomed Technologies (2003) Summary page 1.
- K033759: C2 Nasal Mask, Respironics, Inc. (2004) Summary page 1.

## Most influential descendants
- 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
- K180388: Transcend 365 miniCPAP System (2018), 0 descendants of its own

## Indications for use
The AuraTM CPAP Patient Interface is an accessory to continuous positive airway pressure (CPAP) devices, which are applied to treat Obstructive Sleep Apnea with CPAP or Bi-Level CPAP therapy.

Source page: https://510kreport.com/device/K042130
Methodology: https://510kreport.com/methodology