# K993355: Hudson Rci Concha Column, Cat. NO. 385-40 and Hudson Rci Circuit, Cat. NO. 780-40, 780-41, 780-42, 780-43

- Pathway: 510(k) (Traditional)
- Applicant: Hudson Respiratory Care, Inc.
- Decided: May 24, 2000 after 231 days
- Product code: BTT (Humidifier, Respiratory Gas, (Direct Patient Interface))
- Device class: 2
- Regulation: 21 CFR 868.5450
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
2 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## 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 6, 2011 · Not classified · Z-2790-2011: The packaging may not have been properly sealed, and therefore the sterility of the product cannot be guaranteed.

## Indications for use
When used with Hudson RCI CONCHATHERM healers and Hudson RCI ventilator circuits, the 385-40 Concha Column provides heated humidification for paticnts with and without an artificial airway in place, When used with the Hudson RCI CONCHATHERM heater and Cat. No. 385-40 column the 780-40, 780-41, 780-42, 780-43 circuit provides a gas conduit from the ventilator to the patient and back to the ventilator, and includes both conventional and heated wire circuit modes of neonatal ventilation.

Source page: https://510kreport.com/device/K993355
Methodology: https://510kreport.com/methodology