# K140556: Conchasmart Breathing Circuit

- Pathway: 510(k) (Traditional)
- Applicant: Teleflex, Inc.
- Decided: Sep 24, 2014 after 203 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: 2 generations back to K881625 (1988). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 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 4.

## Indications for use
The ConchaSmart and ISO-GARD Breathing Circuits are intended for adult patients in professional healthcare facilities as a conduit for respiratory gas between a patient and a ventilator and includes heated wire(s) for use with the Hudson RCI Neptune Heated Humidifier. The heated wires are intended to aid in maintaining the set patient temperature and minimize condensation in the breathing circuit.

Source page: https://510kreport.com/device/K140556
Methodology: https://510kreport.com/methodology