# K983112: Respiratory Humidifier, Model # MR850

- Pathway: 510(k) (Traditional)
- Applicant: Fisher & Paykel Healthcare, Ltd.
- Decided: Nov 10, 1998 after 67 days
- Product code: BTT (Humidifier, Respiratory Gas, (Direct Patient Interface))
- Device class: 2
- Regulation: 21 CFR 868.5450
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K913368 (1992). 5 ancestors in all.
73 later devices descend from it; 9 cite it directly.
4 of 79 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913368: Models MR700/MR720/MR730 Dual Servo Resp Humid Acc, Fisher & Paykel Electronics, Ltd. (1992) Summary page 1.
- K953392: HC500 Servo-Controlled Heated Respiratory Humidifier (& Accessories), Fisher & Paykel Electronics, Ltd. (1996) Summary page 1.
- K934140: MR290 Humidification Chamber Single Use, Fisher & Paykel Electronics, Ltd. (1994) Summary page 1.
- K902506: 7200AE Microprocessor Ventilator W/Enhanced Hard., Puritan Bennett Corp. (1991) Summary page 1.

## Most influential descendants
- K020332: Respiratory Humidifier, Model MR850 (2003), 65 descendants of its own
- K033710: MR850 Respiratory Humidifier, Model MR850JHU (2004), 54 descendants of its own
- K073706: Respiratory Humidifier, Model MR850 (2008), 47 descendants of its own
- K092846: Airvo Series Humidifiers (2010), 30 descendants of its own
- K121975: Airvo Humidifier Myairo Humidifier (2013), 25 descendants of its own

## Recalls of this device
- Oct 22, 2008 · Not classified · Z-0414-2009: The recall was initiated because certain lot dates of the RT240 Adult Breathing Circuit Kits manufactured on or before June 27, 2008 include a heated breathing circuit that may be more susceptible to 
- Dec 20, 2005 · Not classified · Z-0695-06: Risk of fire. The manufacturing process may have the potential to damage the insulation of the heater wire in circuits within the specified lot range. This may lead to a potential risk of fire.
- Dec 20, 2005 · Not classified · Z-0696-06: Risk of fire. The manufacturing process may have the potential to damage the insulation of the heater wire in circuits within the specified lot range. This may lead to a potential risk of fire.
- Dec 20, 2005 · Not classified · Z-0694-06: Risk of fire. The manufacturing process may have the potential to damage the insulation of the heater wire in circuits within the specified lot range. This may lead to a potential risk of fire.
- Dec 20, 2005 · Not classified · Z-0697-06: Risk of fire. The manufacturing process may have the potential to damage the insulation of the heater wire in circuits within the specified lot range. This may lead to a potential risk of fire.

## Indications for use
The Fisher & Paykel Healthcare MR850 Humidifier is a Respiratory Gas Humidifier as per 73 BTT, 21 CFR §868.5450. It is intended to add moisture to and warm breathing gases for administration to a patient. The MR850 is intended to be used to warm and add humidity to gases delivered to patients requiring mechanical ventilation, positive pressure breathing assistance or general medical gases. Gases available for medical use do not contain sufficient moisture and may damage or irritate the respiratory tract, or desiccate secretions of patients whose supraglottic airways have been bypassed. Heat is used to increase the water output of the humidifier. Heated breathing tubes are also utilized in order to increase operating efficiency and reduce excessive water and heat loss.

Source page: https://510kreport.com/device/K983112
Methodology: https://510kreport.com/methodology