# K161314: Flexicare FL-9000U Respiratory Humidifier Base

- Pathway: 510(k) (Traditional)
- Applicant: Flexicare Medical Limited.
- Decided: Jul 6, 2016 after 56 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.
1 later device descends from it; 1 cites it directly.
0 of 12 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 4.

## Most influential descendants
- K251448: FL-10000U Respiratory Humidifier (2026), 0 descendants of its own

## Indications for use
The Flexicare FL-9000U Respiratory Humidifier Base is intended to warm and add humidity to gases delivered to patients requiring mechanical ventilation or positive pressure breathing assistance via an endotracheal tube or face mask. For use by trained personnel only within a hospital/institutional environment. This device is intended to be used only with the Flexicare Heated Wire Breathing System and Flexicare Autofill Humidification Chamber.

Source page: https://510kreport.com/device/K161314
Methodology: https://510kreport.com/methodology