# K161412: F&P Brevida™ Nasal Pillows Mask

- Pathway: 510(k) (Traditional)
- Applicant: Fisher & Paykel Healthcare, Ltd.
- Decided: Jan 18, 2017 after 243 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: 9 generations back to K952292 (1995). 29 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120027: Pilairo Nasal Pillows Mask, Fisher & Paykel Healthcare Limited (2012) Summary page 4.

## Most influential descendants
- K200089: F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack/ SML (Small/Medium/Large) A Model, F&P Evora Nasal Mask Nasal Sleep Lab (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack / SML (Small/Medium/Large) Sleep Lab Model (2020), 5 descendants of its own
- K233415: DELTAWAVE Nasal Pillows System (2024), 1 descendant of its own
- K223696: F&P Solo Mask Range (2023), 1 descendant of its own
- K253939: DeltaWave Nasal Pillow System (2026), 0 descendants of its own
- K243583: F&P Nova Nasal Mask (2025), 0 descendants of its own

## Indications for use
The F&P Brevida™ Nasal Pillows Mask is intended to be used by individuals who have been diagnosed by a physician as requiring CPAP or Bi-Level Therapy. The F&P Brevida™ Nasal Pillows Mask is intended for single patient adult (> 661bs (30kgs)) use in the home and multiple patient adult use in the hospital or other clinical setting where proper disinfection of the device can occur between patient uses.

Source page: https://510kreport.com/device/K161412
Methodology: https://510kreport.com/methodology