# K120027: Pilairo Nasal Pillows Mask

- Pathway: 510(k) (Traditional)
- Applicant: Fisher & Paykel Healthcare Limited
- Decided: Feb 23, 2012 after 51 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: 8 generations back to K952292 (1995). 28 ancestors in all.
7 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)
- K063036: Opus HC482 Direct Nasal Mask, Fisher & Paykel Healthcare, Ltd. (2006) Summary page 1.
- K083832: Zest Nasal Mask, Fisher & Paykel Healthcare, Ltd. (2009) Summary page 1.

## Most influential descendants
- K161412: F&P Brevida™ Nasal Pillows Mask (2017), 6 descendants of its own
- 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

## Indications for use
The F&P Pilairo Nasal Pillows Mask is intended to be used by individuals who have been diagnosed by a physician as requiring CPAP or Bi-Level Ventilator treatment. The F&P Pilairo Nasal Pillows Mask is intended for single-patient adult 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/K120027
Methodology: https://510kreport.com/methodology