# K031383: MODEL 780

- Pathway: 510(k) (Special)
- Applicant: Hudson Respiratory Care, Inc.
- Decided: Jul 7, 2003 after 67 days
- Product code: BTT (Humidifier, Respiratory Gas, (Direct Patient Interface))
- Device class: 2
- Regulation: 21 CFR 868.5450
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K881625 (1988). 1 ancestor in all.
4 later devices descend from it; 2 cite it directly.
2 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K881625: Conchatherm Iii Plus Dual Heat Wire Servo Controll, Respiratory Care, Inc. (1988) Summary page 1.

## Most influential descendants
- K061736: Comfort Flo Humidification System and Nasal Cannula (2006), 2 descendants of its own
- 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
- K140556: Conchasmart Breathing Circuit (2014), 0 descendants of its own

## Recalls of this device
- Jul 13, 2026 · Class II · Z-2991-2026: Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit discoloration, melting, smoke, burning odor, or ot
- Jul 9, 2014 · Class II · Z-2107-2014: The temperature probe does not properly connect to the temperature port.
- Apr 17, 2014 · Class II · Z-0419-2016: Product is being recalled due to complaints that the inspiratory and expiratory tubes are transposed.

## Indications for use
The Hudson Heated Wire Ventilator Circuit is intended as a conduit for respiratory gas between a patient and a ventilator, and includes heated wires for use with a Concha Column Humidifier; the heated wires are intended to minimize condensation in the ventilator tubing.

Source page: https://510kreport.com/device/K031383
Methodology: https://510kreport.com/methodology