# K131912: Conchatherm Neptune Heated Humidifier, Comfort Flo Humidification System, Conchasmart Column

- Pathway: 510(k) (Traditional)
- Applicant: Teleflex, Inc.
- Decided: Mar 6, 2014 after 253 days
- Product code: BTT (Humidifier, Respiratory Gas, (Direct Patient Interface))
- Device class: 2
- Regulation: 21 CFR 868.5450
- Recalls of this device: 3 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K913368 (1992). 16 ancestors in all.
1 later device descends from it; 1 cites it directly.
2 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063758: Choncha Therm Neptune Heated Humifier, Choncha Therm Neptune Heated Humifier (Remanufacturer), Model# 425-00,425-00R, Teleflex Medical (2007) Summary page 2.
- K993355: Hudson Rci Concha Column, Cat. NO. 385-40 and Hudson Rci Circuit, Cat. NO. 780-40, 780-41, 780-42, 780-43, Hudson Respiratory Care, Inc. (2000) Summary page 2.
- K061736: Comfort Flo Humidification System and Nasal Cannula, Teleflex Medical (2006) Summary page 2.

## Most influential descendants
- K162242: Comfort Flo Humidification System (2017), 0 descendants of its own

## Recalls of this device
- Dec 13, 2019 · Class I · Z-1115-2020: 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-1114-2020: 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
- Apr 1, 2015 · Class II · Z-1558-2015: Customer complaints were received of power to the unit ceasing and the display going blank.

## Indications for use
To provide a continuous flow of heated and humidified gas to spontaneously breathing patients. When used with the Hudson RCI ConchaTherm Neptune Heated Humidifier and Hudson RCI ventilator circuits, the ConchaSmart Column provides heated humidification for patients with and without an artificial airway in place. The ConchaTherm® Neptune® is a respiratory humidifier designed to heat and humidify respiratory gases delivered via endotracheal tubes, nasal cannula or face masks to adult, pediatric, infant and neonatal patients. This system may be used with either conventional (non-heated wire) breathing circuits or compatible (21-volt) Hudson Respiratory Care Incorporated (RCI) heated-wire circuits. The ConchaTherm® Neptune® can be used with ventilators, continuous flow systems, oxygen diluters and blenders, adjustable nebulizer adapters for aerosol therapy, or non-flammable anesthesia gases to help maintain patient body temperature.

Source page: https://510kreport.com/device/K131912
Methodology: https://510kreport.com/methodology