# K092362: Sleepweaver Nasal Cpap Mask

- Pathway: 510(k) (Traditional)
- Applicant: Circadiance, LLC
- Decided: Nov 2, 2009 after 90 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: 4 generations back to K982530 (1998). 17 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082558: Comfortlite Nasal Mask, Respironics, Inc. (2009) Summary page 1.
- K042403: Mirage Swift, Resmed, Ltd. (2004) Summary page 1.

## Most influential descendants
- K120757: Sleepweaver Elan Nasal Cpap Mask (2012), 1 descendant of its own
- K162905: SleepWeaver 3D Nasal Mask (2017), 0 descendants of its own

## Indications for use
The SleepWeaverTM Nasal CPAP Mask is intended to provide an interface for Continuous Positive Airway Pressure (CPAP) or bi-level therapy. This mask is intended for single-patient reuse in the home and multi-patient, multi-use in the hospital/institutional environment. This mask is to be used on patients greater than 66 lbs/ 30 kg.

Source page: https://510kreport.com/device/K092362
Methodology: https://510kreport.com/methodology