# K162242: Comfort Flo Humidification System

- Pathway: 510(k) (Traditional)
- Applicant: Teleflexmedical, Inc.
- Decided: Jan 19, 2017 after 162 days
- Product code: BTT (Humidifier, Respiratory Gas, (Direct Patient Interface))
- Device class: 2
- Regulation: 21 CFR 868.5450
- Recalls of this device: 2 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K913368 (1992). 17 ancestors in all.
No later device cites it as a predicate yet.
2 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131912: Conchatherm Neptune Heated Humidifier, Comfort Flo Humidification System, Conchasmart Column, Teleflex, Inc. (2014) Summary page 4.

## Recalls of this device
- Dec 13, 2019 · Class I · Z-1113-2020: There is the potential for water to flood the column and enter the circuit under circumstances where an abnormal pressure differential is created between the water bottle and the column during high fl
- Dec 13, 2019 · Class I · Z-1112-2020: There is the potential for water to flood the column and enter the circuit under circumstances where an abnormal pressure differential is created between the water bottle and the column during high fl

## Indications for use
The Comfort Flo Humidification System provides a continuous flow of heated and humidified gas to spontaneously breathing patients. It is indicated for single use by neonate/infant, pediatric, and adult patients in professional healthcare environments.

Source page: https://510kreport.com/device/K162242
Methodology: https://510kreport.com/methodology