# K223684: F&P 820 Humidification System

- Pathway: 510(k) (Traditional)
- Applicant: Fisher & Paykel Healthcare, Ltd.
- Decided: Sep 5, 2023 after 271 days
- Product code: BTT (Humidifier, Respiratory Gas, (Direct Patient Interface))
- Device class: 2
- Regulation: 21 CFR 868.5450
- 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 K913368 (1992). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143646: MR810 System, 900MR810 Adult Single Limb Circuit, 900MR810E Adult Dual Limb Circuit, Fisher & Paykel Healthcare, Ltd. (2015) Summary page 6.
- K983112: Respiratory Humidifier, Model # MR850, Fisher & Paykel Healthcare, Ltd. (1998) Summary page 6.
- K003973: Respiratory Humidifier, Model HC150, Fisher & Paykel Healthcare, Ltd. (2001) Summary page 6.

## Indications for use
F&P 820 System Humidifier Base: The F&P 820 System is intended to provide therapeutic levels of heat and humidity to a patient’s inspired respiratory gases when using a continuous or intermittent ventilator system or a continuous gas flow. This system is intended for both noninvasive and invasive therapies. The addition of heat and humidity to the supply of cold and dry respiratory gases provided through noninvasive or invasive ventilation is beneficial to prevent drying of the patient’s airways. The F&P 820 System is designed for adult and pediatric patients (excluding neonate), requiring a flow range ≥ 5 L/min. It is designed for use in hospitals, long term care facilities and homes, under the prescription of qualified medical professionals. F&P 820A10 Breathing Tubes: The F&P 820 series breathing tubes are an accessory to the F&P 820 System and are compatible with F&P 820 series humidifiers. The F&P 820 System is intended to provide therapeutic levels of heat and humidity to a patient’s inspired respiratory gases when using a continuous or intermittent ventilator system or a continuous gas flow. This system is intended for both noninvasive and invasive therapies. The addition of heat and humidity to the supply of cold and dry respiratory gases provided through noninvasive or invasive ventilation is beneficial to prevent drying of the patient’s airways. This system is designed for adult and pediatric (excluding neonate) use in hospitals, long term care facilities and homes, under the prescription of qualified medical professionals. F&P MR325 Humidification Chamber: The MR325 humidification chamber is an accessory to the F&P 820 System and is compatible with F&P 820 series humidifiers. The F&P 820 System is intended to provide therapeutic levels of heat and humidity to a patient’s inspired respiratory gases when using a continuous or intermittent ventilator system or a continuous gas flow. This system is intended for both noninvasive and invasive therapies. The addition of heat and humidity to the supply of cold and dry respiratory gases provided through noninvasive or invasive ventilation is beneficial to prevent drying of the patient’s airways. This system is designed for adult and pediatric (excluding neonate) use in hospitals, long term care facilities and homes, under the prescription of qualified medical professionals.

Source page: https://510kreport.com/device/K223684
Methodology: https://510kreport.com/methodology