# K250312: Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra Small

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, LP
- Decided: Jul 2, 2025 after 149 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
Hudson RCI® Comfort Flo Nasal Cannulas Premature, Infant: Hudson RCI® Comfort Flo Nasal Cannulas Premature, Infant are intended to be used in conjunction with the Comfort Flo Humidification System to provide a continuous flow of heated and humidified air/oxygen mixtures to spontaneously breathing patients. It is indicated for single use by premature and infant (birth to 2 years) patients in professional healthcare environments. Hudson RCI® Comfort Flo® Plus Cannulas and Comfort Flo® Soft Plus Cannulas Extra Small: Hudson RCI® Comfort Flo® Plus Cannulas and Comfort Flo® Soft Plus Cannulas Extra Small are intended to be used in conjunction with the Humidification System to provide a continuous flow of heated and humidified air/oxygen mixtures to spontaneously breathing patients. It is indicated for single use by adult and pediatric (12 years and above) patients in professional healthcare environments.

Source page: https://510kreport.com/device/K250312
Methodology: https://510kreport.com/methodology