Hudson RCI Comfort Flo® CubCannula
FDA 510(k) K241778 · Medline Industries, LP
510(k) numberK241778
Submission
- Device name
- Hudson RCI Comfort Flo® CubCannula
- Applicant
- Medline Industries, LP
Northfiled, IL, US - Received
- June 20, 2024
- Decision date
- December 19, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BTT – Humidifier, Respiratory Gas, (Direct Patient Interface)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5450
- Specialty
- Anesthesiology
Other 510(k)s with product code BTT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262268 | Optiflow Oxygen Kit (AA484J)BTT · Special | Fisher and Paykel Healthcare Limited | 08/27/2026SE |
| K254078 | HVT 2.0BTT · Traditional | Vapotherm, Inc. | 04/13/2026SE |
| K251448 | FL-10000U Respiratory HumidifierBTT · Traditional | Flexicare Medical Limited. | 01/16/2026SE |
| K251419 | Laboratorios Biogalenic Sterile Water for Inhalation, USPBTT · Traditional | Laboratorios Biogalenic S.A. DE C.V. | 01/14/2026SE |
| K253479 | Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)BTT · Special | Fisher & Paykel Healthcare, Ltd. | 12/19/2025SE |
| K250312 | Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus…BTT · Traditional | Medline Industries, LP | 07/02/2025SE |
| K251611 | Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944)…BTT · Special | Fisher & Paykel Healthcare, Ltd. | 06/25/2025SE |
| K242717 | Laboratorios Biogalenic Sterile Water for Inhalation, USPBTT · Traditional | Laboratorios Biogalenic S.A. DE C.V. | 01/30/2025SE |
| K240163 | Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus CannulaBTT · Traditional | Medline Industries, LP | 09/27/2024SE |
| K234058 | F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J)BTT · Traditional | Fisher & Paykel Healthcare, Ltd. | 08/08/2024SE |
More from Fisher & Paykel Healthcare, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K253526 | NAMIC Dilator and SheathDYB · Traditional | 07/29/2026SE |
| K254287 | Medline Reusable Blood Pressure CuffDXQ · Traditional | 06/22/2026SE |
| K253322 | Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78 Infant…BZE · Traditional | 03/25/2026SE |
| K251687 | Konig Bell Circumcision ClampHFX · Traditional | 02/25/2026SE |
| K253070 | Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL)DXC · Traditional | 11/20/2025SE |
| K250345 | Medline Bag DecanterLHI · Traditional | 10/24/2025SE |
| K250312 | Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus…BTT · Traditional | 07/02/2025SE |
| K243888 | Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemJDR · Traditional | 04/11/2025SE |
| K242844 | Medline Level 4 Surgical Gown with Breathable SleevesFYA · Traditional | 02/26/2025SE |
| K242370 | Medline Microdissection Needle (4cm) (140936 (ESE104A)); Medline Microdissection Needle…GEI · Traditional | 12/19/2024SE |
Questions and answers
When was Hudson RCI Comfort Flo® CubCannula cleared by the FDA?
Hudson RCI Comfort Flo® CubCannula (K241778) received a 510(k) decision of Substantially Equivalent on December 19, 2024, 182 days after the submission was received.
What is the product code of K241778?
The FDA product code is BTT – Humidifier, Respiratory Gas, (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5450.