# K223696: F&P Solo Mask Range

- Pathway: 510(k) (Traditional)
- Applicant: Fisher & Paykel Healthcare, Ltd.
- Decided: May 17, 2023 after 159 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: 11 generations back to K952292 (1995). 31 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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, Fisher & Paykel Healthcare, Ltd. (2020) Summary page 4.

## Most influential descendants
- K233829: Nova Micro Pillows Mask Small A Model (NVP1SA); Nova Micro Pillows Mask Medium A Model (NVP1MA); Nova Micro Pillows Mask Large A Model (NVP1LA); Nova Micro Pillows Mask Fit Pack/SML A Model (NVP1SMLA); Nova Micro Pillows Mask Small Sleep Lab A (NVP1SSLA); Nova Micro Pillows Mask Medium Sleep Lab A (NVP1MSLA); Nova Micro Pillows Mask Large Sleep Lab A (NVP1LSLA); Nova Micro Pillows Mask Fit Pack Sleep Lab A (NVP1SMLSLA) (2024), 0 descendants of its own

## Indications for use
A-Model The F&P Solo mask is intended to be used by adults weighing ≥66lbs (30 kgs) who have been prescribed non-invasive positive airway pressure therapy such as CPAP or Bi-Level by a physician. The F&P Solo mask is intended for single-patient use in the home. SL A-Model The F&P Solo mask is intended to be used by adults weighing ≥66lbs (30 kgs) who have been prescribed non-invasive positive airway pressure therapy such as CPAP or Bi-Level by a physician. The F&P Solo mask is intended for single-patient use in the home and for multiple patient 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/K223696
Methodology: https://510kreport.com/methodology