# K130481: Sleepweaver Anew Full Face Soft Cloth Pap Mask

- Pathway: 510(k) (Traditional)
- Applicant: Circadiance, LLC
- Decided: May 24, 2013 after 88 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) SleepWeaver Nasal CPAP Mask: named in the summary without a submission number
- (no number) Mirage Quattro: named in the summary without a submission number

## Indications for use
The SleepWeaver Anew Full Face Soft Cloth PAP Mask is intended to provide an interface for Positive Airway Pressure (PAP) therapy. This mask is intended for single-patient reuse in the home and 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/K130481
Methodology: https://510kreport.com/methodology