FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra Small
K Number: K250312
·
Decision Jul 2, 2025
Classifications
1
FEI Numbers
108
Registration Numbers
108
Same Product Code
220
Applicant Total
29
Review Days
149
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Basic Information
- Device Name
- Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra Small
- K Number
- K250312
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5450
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medline Industries, LP
- Date Received
- February 3, 2025
- Decision Date
- July 2, 2025
- Product Code
- BTT
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | FDA class 2 | Anesthesiology |
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|---|---|---|---|
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| K240163 | Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus Cannula | Sep 27, 2024 | Substantially Equivalent |
| K234132 | Medline Reusable Sterilization Wrappers | Sep 17, 2024 | Substantially Equivalent |