# K122847: Kangaroo Nasal Mask

- Pathway: 510(k) (Special)
- Applicant: Respironics, Inc.
- Decided: Mar 6, 2013 after 169 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 K945938 (1996). 28 ancestors in all.
3 later devices descend from it; 1 cites it directly.
1 of 32 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110008: Golife Nasal Mask, Respironics, Inc. (2011) Summary page 1.
- K110405: Trublue Nasal Mask, Respironics, Inc. (2011) Summary page 1.

## Most influential descendants
- K140980: TI Nasal Mask (2015), 2 descendants of its own
- K210844: DreamWear Silicone Pillows Mask (2021), 1 descendant of its own
- K253166: F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S) (2026), 0 descendants of its own

## Indications for use
The Kangaroo 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 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/K122847
Methodology: https://510kreport.com/methodology