# K063758: Choncha Therm Neptune Heated Humifier, Choncha Therm Neptune Heated Humifier (Remanufacturer), Model# 425-00,425-00R

- Pathway: 510(k) (Traditional)
- Applicant: Teleflex Medical
- Decided: Apr 23, 2007 after 125 days
- Product code: BTT (Humidifier, Respiratory Gas, (Direct Patient Interface))
- Device class: 2
- Regulation: 21 CFR 868.5450
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K913368 (1992). 10 ancestors in all.
2 later devices descend from it; 1 cites it directly.
2 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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

## Recalls of this device
- Jun 12, 2012 · Class II · Z-2036-2012: Speaker Failure. If the speaker fails and an event occurs which would generate an audio alarm, the alarm will not sound and could cause a potential delay in patient treatment.
- Jan 12, 2010 · Not classified · Z-1040-2010: When turned on, the Neptune heater may cause an artifact on the patient's heart monitor.

## Indications for use
The ConchaTherm® Neptune TM 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 TM 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/K063758
Methodology: https://510kreport.com/methodology