F&P Optiflow Air/Oxygen Flow Source
FDA 510(k) K243917 · Fisher & Paykel Healthcare, Ltd.
510(k) numberK243917
Submission
- Device name
- F&P Optiflow Air/Oxygen Flow Source
- Applicant
- Fisher & Paykel Healthcare, Ltd.
Auckland, NZ - Received
- December 20, 2024
- Decision date
- July 14, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BZR – Mixer, Breathing Gases, Anesthesia Inhalation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5330
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
Other 510(k)s with product code BZR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241465 | Midas Flowmeter; eAVSBZR · Traditional | Parker Hannifin Corporation | 09/19/2024SE |
| K231895 | Maxtec MaxBlend2+pBZR · Traditional | Maxtec, LLC | 12/04/2023SE |
| K230987 | FlowStar Analog Mixer FlowmeterBZR · Traditional | Baldus Sedation GmbH & Co. KG | 09/14/2023SE |
| K222794 | FlowStar Touch Digital Mixer FlowmeterBZR · Traditional | Baldus Sedation GmbH & Co. KG | 07/28/2023SE |
| K221494 | Quality Mix Blender, OxymixerBZR · Traditional | Dehas Medical Systems GmbH | 01/23/2023SE |
| K202480 | Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50BZR · Traditional | Parker Hannifin | 04/22/2021SE |
| K173205 | Equinox AdvantageBZR · Traditional | O-Two Medical Technologies, Inc. | 08/29/2018SE |
| K161718 | MaxBlend 2, MaxBlend LiteBZR · Traditional | Maxtec, LLC | 10/27/2016SE |
| K142291 | GMX Series Medical Air/Oxygen BlenderBZR · Traditional | Gentec (Shanghai) Corporation | 05/19/2015SE |
| K113687 | Equinox RelieveBZR · Traditional | O-Two Medical Technologies, Inc. | 04/30/2012SE |
More from O-Two Medical Technologies, Inc.
| 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 |
| 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 |
| K234058 | F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J)BTT · Traditional | 08/08/2024SE |
| 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 Air/Oxygen Flow Source cleared by the FDA?
F&P Optiflow Air/Oxygen Flow Source (K243917) received a 510(k) decision of Substantially Equivalent on July 14, 2025, 206 days after the submission was received.
What is the product code of K243917?
The FDA product code is BZR – Mixer, Breathing Gases, Anesthesia Inhalation, a Class II (moderate risk) device regulated under 21 CFR 868.5330.