# K143646: MR810 System, 900MR810 Adult Single Limb Circuit, 900MR810E Adult Dual Limb Circuit

- Pathway: 510(k) (Traditional)
- Applicant: Fisher & Paykel Healthcare, Ltd.
- Decided: Mar 5, 2015 after 73 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: 8 generations back to K913368 (1992). 12 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131957: MR810RESPIRATORY Humidifier, 900MR810 Adult Single Limb Circuit, 900MR810E Adult Dual Limb Circuit, Fisher & Paykel Healthcare, Ltd. (2013) Summary page 4.

## Most influential descendants
- K223684: F&P 820 Humidification System (2023), 0 descendants of its own

## Indications for use
The Fisher & Paykel MR810 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 system. The MR810 System is intended for both non-invasive and invasive therapies. Addition of heat and humidity to the supply of cold and dry respiratory gases provided through non-invasive or invasive ventilation is beneficial to prevent drying of the patient airways. The MR810 System is for use for adult and pediatric patients requiring a flow range ≥5 L/min. The MR810 System is designed for use in hospitals, long term care facilities and homes under the prescription of a qualified medical professional.

Source page: https://510kreport.com/device/K143646
Methodology: https://510kreport.com/methodology