# K162905: SleepWeaver 3D Nasal Mask

- Pathway: 510(k) (Traditional)
- Applicant: Circadiance, LLC
- Decided: Mar 15, 2017 after 149 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: 6 generations back to K982530 (1998). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120757: Sleepweaver Elan Nasal Cpap Mask, Circadiance, LLC (2012) Summary page 5.

## Indications for use
The SleepWeaver 3D Nasal 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 single-patient reuse 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/K162905
Methodology: https://510kreport.com/methodology