# K251448: FL-10000U Respiratory Humidifier

- Pathway: 510(k) (Traditional)
- Applicant: Flexicare Medical Limited.
- Decided: Jan 16, 2026 after 252 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: 7 generations back to K913368 (1992). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161314: Flexicare FL-9000U Respiratory Humidifier Base, Flexicare Medical Limited. (2016) Summary page 5.

## Indications for use
The Flexicare FL-10000U Respiratory Humidifier 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 with the Flexicare Autofill Humidification Chamber and Flexicare Heated Wire Breathing Circuit.

Source page: https://510kreport.com/device/K251448
Methodology: https://510kreport.com/methodology