# K102224: Pixi Pediatric Mask

- Pathway: 510(k) (Traditional)
- Applicant: Resmed, Ltd.
- Decided: Dec 10, 2010 after 126 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 K945938 (1996). 23 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090935: Minime Pediatric Mask, Sleepnet Corporation (2009) Summary page 1.

## Most influential descendants
- K120920: Hsiner Cpap Silicone Nasal Mask Size XS/Petite  Hsiner Nasal Pillow Mask Hsiner Infant Cpap Cannula (2012), 1 descendant of its own
- K243225: Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes M); Nasal Pillow Mask - Large (NNPM-03/ Nefes L) (2024), 0 descendants of its own
- K151683: SleepWeaver Advance Pediatric Nasal CPAP Mask (2016), 0 descendants of its own

## Indications for use
The Pixi Pediatric mask channels airflow noninvasively to a patient from a continuous positive airway pressure (CPAP) or bilevel device. The Pixi Pediatric mask is: * to be used by children aged between 2 and 7 for whom continuous positive airway pressure (CPAP) or bilevel therapy has been prescribed * intended for single-patient re-use in the home environment and single-patient re-use in the hospital/institutional environment

Source page: https://510kreport.com/device/K102224
Methodology: https://510kreport.com/methodology