# K151683: SleepWeaver Advance Pediatric Nasal CPAP Mask

- Pathway: 510(k) (Traditional)
- Applicant: Circadiance, LLC
- Decided: Apr 5, 2016 after 288 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: 5 generations back to K945938 (1996). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102224: Pixi Pediatric Mask, Resmed, Ltd. (2010) Summary page 5.

## Indications for use
The SleepWeaver Advance Pediatric Nasal Mask is intended to provide an interface for noninvasive Positive Airway Pressure (PAP) ventilation therapy. This mask is intended for single-patient use in the home and single-patient use in the hospital / institutional environment. This mask is to be used on patients between 2 and 7 years of age.

Source page: https://510kreport.com/device/K151683
Methodology: https://510kreport.com/methodology