Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra Small (K250312)
Description
Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra Small by Medline Industries, LP, an FDA 510(k) cleared anesthesiology device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250312
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra Small (K250312) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K222197 | F&P Optiflow Junior 2/2+ Nasal Cannula Interface Range | Fisher & Paykel Healthcare, Ltd. | 2023 |
| K191818 | F&P Optiflow 3S Nasal Cannula (Small, Medium, Large) | Fisher & Paykel Healthcare, Ltd. | 2020 |
Trace the full predicate network for K250312
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.