K250312 is an FDA 510(k) clearance for the Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant. 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 July 2, 2025, 149 days after receiving the submission on February 3, 2025.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5450.
| 510(k) Number | K250312 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 03, 2025 |
| Decision Date | July 02, 2025 |
| Days to Decision | 149 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 |