510(k) K250312
K250312 is an FDA 510(k) premarket notification submitted by Medline Industries, LP for the device "Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra Small". The FDA issued a decision of Substantially Equivalent on July 2, 2025. The device falls under product code BTT (Humidifier, Respiratory Gas, (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5450. Medline Industries, LP has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 2, 2025
- Date Received
- February 3, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Humidifier, Respiratory Gas, (Direct Patient Interface)
- Device Class
- Class II
- Regulation Number
- 868.5450
- Review Panel
- AN
- Submission Type