# K061736: Comfort Flo Humidification System and Nasal Cannula

- Pathway: 510(k) (Traditional)
- Applicant: Teleflex Medical
- Decided: Aug 18, 2006 after 59 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: 5 generations back to K913368 (1992). 13 ancestors in all.
2 later devices descend from it; 1 cites it directly.
2 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031383: MODEL 780, Hudson Respiratory Care, Inc. (2003) Summary page 2.
- K010402: Smooth-Flo Circuit, Hudson Respiratory Care, Inc. (2001) Summary page 2.
- K923946: Conchatherm IV Heated Molecular Humidifier, Hudson Respiratory Care, Inc. (1994) Summary page 2.
- K033710: MR850 Respiratory Humidifier, Model MR850JHU, Fisher & Paykel Healthcare, Ltd. (2004) Summary page 2.

## Most influential descendants
- K131912: Conchatherm Neptune Heated Humidifier, Comfort Flo Humidification System, Conchasmart Column (2014), 1 descendant of its own
- K162242: Comfort Flo Humidification System (2017), 0 descendants of its own

## Indications for use
To provide a continuous flow of heated and humidified gas to spontaneously breathing patients.

Source page: https://510kreport.com/device/K061736
Methodology: https://510kreport.com/methodology