F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J)
FDA 510(k) K234058 · Fisher & Paykel Healthcare, Ltd.
510(k) numberK234058
Submission
- Device name
- F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J)
- Applicant
- Fisher & Paykel Healthcare, Ltd.
Auckland, NZ - Received
- December 22, 2023
- Decision date
- August 8, 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 |
| K241778 | Hudson RCI Comfort Flo® CubCannulaBTT · Traditional | Medline Industries, LP | 12/19/2024SE |
| K240163 | Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus CannulaBTT · Traditional | Medline Industries, LP | 09/27/2024SE |
More from Medline Industries, LP
| 510(k) | Device | Decision |
|---|---|---|
| K253479 | Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)BTT · Special | 12/19/2025SE |
| K250651 | OptiPAP Junior Flexi Tube US (OPTIPAPFUS); OptiPAP Junior Nasal Prongs XXS…SGR · Traditional | 11/19/2025SE |
| K252173 | F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size A…CBK · Traditional | 09/10/2025SE |
| K243917 | F&P Optiflow Air/Oxygen Flow SourceBZR · Traditional | 07/14/2025SE |
| K251611 | Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944)…BTT · Special | 06/25/2025SE |
| K243583 | F&P Nova Nasal MaskBZD · Traditional | 06/18/2025SE |
| K234053 | F&P Optiflow Flow DiverterCBP · Traditional | 08/09/2024SE |
| K233643 | F&P Airvo 3 NIV (PT311US)MNT · Traditional | 08/09/2024SE |
| K233821 | F&P Optiflow Oxygen Kit (AA451J)BTT · Traditional | 06/13/2024SE |
| K222292 | F&P myAirvo 3BTT · Traditional | 05/08/2024SE |
Questions and answers
When was F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J) cleared by the FDA?
F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J) (K234058) received a 510(k) decision of Substantially Equivalent on August 8, 2024, 230 days after the submission was received.
What is the product code of K234058?
The FDA product code is BTT – Humidifier, Respiratory Gas, (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5450.