K240163 is an FDA 510(k) clearance for the Hudson RCI® Comfort Flo Nasal Cannula. This device is classified as a Humidifier, Respiratory Gas, (direct Patient Interface) (Class II - Special Controls, product code BTT).
Submitted by Medline Industries, LP (Northfiled, US). The FDA issued a Cleared decision on September 27, 2024, 249 days after receiving the submission on January 22, 2024.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5450.
| 510(k) Number | K240163 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 22, 2024 |
| Decision Date | September 27, 2024 |
| Days to Decision | 249 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BTT — Humidifier, Respiratory Gas, (direct Patient Interface) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5450 |