# K020332: Respiratory Humidifier, Model MR850

- Pathway: 510(k) (Traditional)
- Applicant: Fisher & Paykel Healthcare, Ltd.
- Decided: Jul 7, 2003 after 522 days
- Product code: BTT (Humidifier, Respiratory Gas, (Direct Patient Interface))
- Device class: 2
- Regulation: 21 CFR 868.5450
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K913368 (1992). 7 ancestors in all.
65 later devices descend from it; 5 cite it directly.
4 of 73 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983112: Respiratory Humidifier, Model # MR850, Fisher & Paykel Healthcare, Ltd. (1998) Summary page 1.
- K000697: Modification to Airlife Heated Ventilator and Anesthesia Breathing Circuits, Allegiance Healthcare Corp. (2000)

## Most influential descendants
- 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
- K131895: Airvo 2 Humidifier, Myairvo 2 Humidifier (2013), 24 descendants of its own

## Recalls of this device
- Dec 21, 2004 · Not classified · Z-0553-05: Pressure elbow may be partly occluded.

## Indications for use
The Fisher & Paykel Healthcare MR850 Humidifier is intended to be used to warm and add humidity to gases delivered to patients requiring mechanical ventilation or positive pressure breathing assistance or general medical gases. The heated-wire breathing circuits are intended as conduits of breathing gas for ventilation of patients, and to maintain the temperature of humidified inspired gas, to reduce condensation. They are accessories for the Fisher & Paykel Healthcare MR850 Respiratory Gas Humidifier. The RT130 is used for flow rates between 0.3 and 4 L/min, and the RT131 is for flow rates greater than 4 L/min, for neonatal patients.

Source page: https://510kreport.com/device/K020332
Methodology: https://510kreport.com/methodology