Fisher & Paykel Healthcare, Ltd.
FDA 510(k) & PMA Approved Devices — 25 products
Total Devices25
Categories7
Latest Approval2025-12-19
| Type | Number | Device Name | Code | Date | |
|---|---|---|---|---|---|
| 510(k) | K253479 | Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J) | BTT | 2025-12-19 | View |
| 510(k) | K250651 | OptiPAP Junior Flexi Tube US (OPTIPAPFUS); OptiPAP Junior Nasal Prongs XXS (OPTIPAPPXXS); OptiPAP Junior Nasal Prongs XS (OPTIPAPPXS); OptiPAP Junior Nasal Prongs S (OPTIPAPPS); OptiPAP Junior Nasal Prongs M (OPTIPAPPM); OptiPAP Junior Nasal Prongs L (OPTIPAPPL); OptiPAP Junior Nasal Prongs XL (OPTIPAPPXL); OptiPAP Junior Nasal Mask XXS (OPTIPAPMXXS); OptiPAP Junior Nasal Mask XS (OPTIPAPMXS); OptiPAP Junior Nasal Mask S (OPTIPAPMS); OptiPAP Junior Nasal Mask M (OPTIPAPMM); OptiPAP Jun | SGR | 2025-11-19 | View |
| 510(k) | K252173 | F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size A (ONIV117A); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size B (ONIV117B); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size C (ONIV117C); F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask with optional Expiratory Filter Compatible with Single-limb Circuits - Size A (ONIV117A-F); F&P OptiNIV ONIV117-F Hospital Vented Full | CBK | 2025-09-10 | View |
| 510(k) | K243917 | F&P Optiflow Air/Oxygen Flow Source | BZR | 2025-07-14 | View |
| 510(k) | K251611 | Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944); Optiflow+ Nasal Cannula - Large (OPT946); Optiflow+ Nasal Cannula Small (MYOPT9SMALL); Optiflow+ Nasal Cannula Medium (MYOPT9MEDIUM); Optiflow+ Nasal Cannula Large (MYOPT9LARGE) | BTT | 2025-06-25 | View |
| 510(k) | K234053 | F&P Optiflow Flow Diverter | CBP | 2024-08-09 | View |
| 510(k) | K233643 | F&P Airvo 3 NIV (PT311US) | MNT | 2024-08-09 | View |
| 510(k) | K234058 | F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J) | BTT | 2024-08-08 | View |
| 510(k) | K233821 | F&P Optiflow Oxygen Kit (AA451J) | BTT | 2024-06-13 | View |
| 510(k) | K231956 | F&P Optiflow+ Duet Nasal Cannula | BTT | 2024-02-07 | View |
| 510(k) | K223684 | F&P 820 Humidification System | BTT | 2023-09-05 | View |
| 510(k) | K221436 | F&P 950 Accessory Breathing Circuit Kits | BZD | 2023-06-29 | View |
| 510(k) | K223696 | F&P Solo Mask Range | BZD | 2023-05-17 | View |
| 510(k) | K222197 | F&P Optiflow Junior 2/2+ Nasal Cannula Interface Range | BTT | 2023-04-06 | View |
| 510(k) | K212031 | F&P 850 AirSpiral Adult NIV and NHF Circuit Kit | BTT | 2022-04-22 | View |
| 510(k) | K212371 | F&P Evora Full Face Mask | BZD | 2022-03-18 | View |
| 510(k) | K211096 | Optiflow Oxygen Kit | BTT | 2022-01-28 | View |
| 510(k) | K203449 | F&P Visairo NIV Mask Range | CBK | 2021-04-14 | View |
| 510(k) | K201723 | F&P Optiflow Nasal Oxygen Cannula with CO2 Sampling | BTT | 2021-03-16 | View |
| 510(k) | K200089 | F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack/ SML (Small/Medium/Large) A Model, F&P Evora Nasal Mask Nasal Sleep Lab (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack / SML (Small/Medium/Large) Sleep Lab Model | BZD | 2020-06-02 | View |
| 510(k) | K191818 | F&P Optiflow 3S Nasal Cannula (Small, Medium, Large) | BTT | 2020-03-19 | View |
| 510(k) | K190713 | F&P Vitera Mask Full Face A Model (Small, Medium, Large), F&P Vitera Mask Full Face Sleep Lab Model (Small, Medium, Large) | BZD | 2019-10-11 | View |
| 510(k) | K173193 | F&P SleepStyle | BZD | 2018-08-08 | View |
| 510(k) | K161686 | F&P InfoSmart | BZD | 2017-01-24 | View |
| 510(k) | K161412 | F&P Brevida Nasal Pillows Mask | BZD | 2017-01-18 | View |
No matching devices.