# K100554: Respiratory Humidifier , Heated Delivery System, Adaptor, Models MR880, RT241, 900MR441

- Pathway: 510(k) (Traditional)
- Applicant: Fisher & Paykel Healthcare, Ltd.
- Decided: May 28, 2010 after 91 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: 6 generations back to K913368 (1992). 10 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073706: Respiratory Humidifier, Model MR850, Fisher & Paykel Healthcare, Ltd. (2008) Summary page 1.

## Most influential descendants
- K131957: MR810RESPIRATORY Humidifier, 900MR810 Adult Single Limb Circuit, 900MR810E Adult Dual Limb Circuit (2013), 3 descendants of its own
- K143646: MR810 System, 900MR810 Adult Single Limb Circuit, 900MR810E Adult Dual Limb Circuit (2015), 1 descendant of its own
- K223684: F&P 820 Humidification System (2023), 0 descendants of its own
- K141940: Conchasmart Column (2014), 0 descendants of its own

## Indications for use
The Fisher & Paykel Healthcare 880 Respiratory Humidification System (880 System) is intended to be used to warm and humidify breathing gases delivered to spontaneously breathing patients requiring assisted breathing and / or mucosal humidification. The system is intended to be used in a hospital environment by trained healthcare providers. The 880 System is designed for use with an air-oxygen mix, up to 100% oxygen, provided by an external flow source. The flow may be from 5 L/min to 45 L/min depending on the type of patient interface.

Source page: https://510kreport.com/device/K100554
Methodology: https://510kreport.com/methodology