# K241778: Hudson RCI Comfort Flo® CubCannula™

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, LP
- Decided: Dec 19, 2024 after 182 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: 11 generations back to K913368 (1992). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222197: F&P Optiflow Junior 2/2+ Nasal Cannula Interface Range, Fisher & Paykel Healthcare, Ltd. (2023) Summary page 5.

## Indications for use
The Hudson RCI Comfort Flo® CubCannula™ is a single use nasal cannula intended to administer respiratory gas to a spontaneously breathing patient through both nostrils delivering flow rates ranging from 1 to 25 LPM. CubCannula™ is a patient interface used to deliver heated and humidified gas to the following populations: * Neonates, birth to 1 month of age * Infants, 1 month to 2 years of age * Children, 2 to 12 years of age CubCannula™ is designed for use in professional healthcare environments and must be prescribed by a physician. CubCannula is used in conjunction with the Humidification System intended to provide a continuous flow of heated and humidified air/oxygen mixtures to spontaneously breathing patients.

Source page: https://510kreport.com/device/K241778
Methodology: https://510kreport.com/methodology