Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Fisher & Paykel Healthcare, Ltd. · Predicate Candidate Screening
70 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
182 daysmedian FDA review time
359 days90th percentile
70clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253479 | Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling | Fisher & Paykel Healthcare, Ltd. | 2025-12-19 | 66 | 0 |
| K250651 | OptiPAP Junior Flexi Tube US (OPTIPAPFUS); OptiPAP Junior Na | Fisher & Paykel Healthcare, Ltd. | 2025-11-19 | 260 | 0 |
| K252173 | F&P OptiNIV Hospital Vented Full Face Mask Compatible with S | Fisher & Paykel Healthcare, Ltd. | 2025-09-10 | 61 | 0 |
| K243917 | F&P Optiflow Air/Oxygen Flow Source | Fisher & Paykel Healthcare, Ltd. | 2025-07-14 | 206 | 0 |
| K251611 | Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Ca | Fisher & Paykel Healthcare, Ltd. | 2025-06-25 | 29 | 0 |
| K233643 | F&P Airvo 3 NIV (PT311US) | Fisher & Paykel Healthcare, Ltd. | 2024-08-09 | 270 | 0 |
| K234053 | F&P Optiflow Flow Diverter | Fisher & Paykel Healthcare, Ltd. | 2024-08-09 | 231 | 0 |
| K234058 | F&P Optiflow Filtered Nasal Interface with Anesthesia Mask C | Fisher & Paykel Healthcare, Ltd. | 2024-08-08 | 230 | 0 |
| K233821 | F&P Optiflow Oxygen Kit (AA451J) | Fisher & Paykel Healthcare, Ltd. | 2024-06-13 | 195 | 0 |
| K231956 | F&P Optiflow+ Duet Nasal Cannula | Fisher & Paykel Healthcare, Ltd. | 2024-02-07 | 219 | 0 |
| K223684 | F&P 820 Humidification System | Fisher & Paykel Healthcare, Ltd. | 2023-09-05 | 271 | 0 |
| K221436 | F&P 950 Accessory Breathing Circuit Kits | Fisher & Paykel Healthcare, Ltd. | 2023-06-29 | 408 | 0 |
| K223696 | F&P Solo Mask Range | Fisher & Paykel Healthcare, Ltd. | 2023-05-17 | 159 | 0 |
| K222197 | F&P Optiflow Junior 2/2+ Nasal Cannula Interface Range | Fisher & Paykel Healthcare, Ltd. | 2023-04-06 | 258 | 0 |
| K212031 | F&P 850 AirSpiral Adult NIV and NHF Circuit Kit | Fisher & Paykel Healthcare, Ltd. | 2022-04-22 | 297 | 0 |
| K212371 | F&P Evora Full Face Mask | Fisher & Paykel Healthcare, Ltd. | 2022-03-18 | 231 | 0 |
| K211096 | Optiflow Oxygen Kit | Fisher & Paykel Healthcare, Ltd. | 2022-01-28 | 290 | 0 |
| K203449 | F&P Visairo NIV Mask Range | Fisher & Paykel Healthcare, Ltd. | 2021-04-14 | 142 | 0 |
| K201723 | F&P Optiflow Nasal Oxygen Cannula with CO2 Sampling | Fisher & Paykel Healthcare, Ltd. | 2021-03-16 | 266 | 0 |
| K200089 | F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wi | Fisher & Paykel Healthcare, Ltd. | 2020-06-02 | 139 | 0 |
| K191818 | F&P Optiflow 3S Nasal Cannula (Small, Medium, Large) | Fisher & Paykel Healthcare, Ltd. | 2020-03-19 | 258 | 0 |
| K190713 | F&P Vitera Mask Full Face A Model (Small, Medium, Large), F& | Fisher & Paykel Healthcare, Ltd. | 2019-10-11 | 206 | 0 |
| K173193 | F&P SleepStyle | Fisher & Paykel Healthcare, Ltd. | 2018-08-08 | 310 | 0 |
| K161686 | F&P InfoSmart | Fisher & Paykel Healthcare, Ltd. | 2017-01-24 | 221 | 0 |
| K161412 | F&P Brevida™ Nasal Pillows Mask | Fisher & Paykel Healthcare, Ltd. | 2017-01-18 | 243 | 0 |
| K143646 | MR810 System, 900MR810 Adult Single Limb Circuit, 900MR810E | Fisher & Paykel Healthcare, Ltd. | 2015-03-05 | 73 | 0 |
| K132017 | HC550 RESPIRATORY HUMIDIFIER, ADULT VENTILATOR CIRCUIT | Fisher & Paykel Healthcare, Ltd. | 2014-03-25 | 267 | 0 |
| K133666 | RT016 INSPIRATORY FILTER | Fisher & Paykel Healthcare, Ltd. | 2014-02-05 | 68 | 0 |
| K131957 | MR810RESPIRATORY HUMIDIFIER, 900MR810 ADULT SINGLE LIMB CIRC | Fisher & Paykel Healthcare, Ltd. | 2013-12-04 | 160 | 0 |
| K131895 | AIRVO 2 HUMIDIFIER, MYAIRVO 2 HUMIDIFIER | Fisher & Paykel Healthcare, Ltd. | 2013-10-24 | 121 | 2 |
| K121975 | AIRVO HUMIDIFIER MYAIRO HUMIDIFIER | Fisher & Paykel Healthcare, Ltd. | 2013-01-03 | 182 | 0 |
| K122432 | ADULT EVAQUA 2' DUAL HEATED BREATHING CIRCUITS | Fisher & Paykel Healthcare, Ltd. | 2012-12-06 | 118 | 0 |
| K103767 | DUAL HEATED INFANT VREATHING CIROUITS | Fisher & Paykel Healthcare, Ltd. | 2012-04-16 | 480 | 0 |
| K110019 | RESPIRATORY HUMIDIFER | Fisher & Paykel Healthcare, Ltd. | 2012-03-30 | 452 | 0 |
| K110316 | INFOSEND GSM | Fisher & Paykel Healthcare, Ltd. | 2011-08-19 | 197 | 0 |
| K103786 | ZEST PETITE NASAL MASK | Fisher & Paykel Healthcare, Ltd. | 2011-03-24 | 87 | 0 |
| K100011 | FISHER & PAYKEL HEALTHCARE BUBBLE CPAP SYSTEM | Fisher & Paykel Healthcare, Ltd. | 2010-10-08 | 277 | 0 |
| K100554 | RESPIRATORY HUMIDIFIER , HEATED DELIVERY SYSTEM, ADAPTOR, MO | Fisher & Paykel Healthcare, Ltd. | 2010-05-28 | 91 | 0 |
| K094040 | F&P ICON SERIES CPAP | Fisher & Paykel Healthcare, Ltd. | 2010-04-27 | 118 | 1 |
| K092846 | AIRVO SERIES HUMIDIFIERS | Fisher & Paykel Healthcare, Ltd. | 2010-01-27 | 134 | 0 |
| K083832 | ZEST NASAL MASK | Fisher & Paykel Healthcare, Ltd. | 2009-03-16 | 83 | 0 |
| K083122 | HOSPITAL FULL FACE MASK NON VENTED, MODEL: RT041 | Fisher & Paykel Healthcare, Ltd. | 2009-03-04 | 133 | 0 |
| K080209 | FISHER AND PAYKEL HEALTHCARE ZEST NASAL MASK | Fisher & Paykel Healthcare, Ltd. | 2008-09-12 | 228 | 0 |
| K081029 | SLEEPSTYLE 200 AUTO SERIES HC254 | Fisher & Paykel Healthcare, Ltd. | 2008-09-12 | 154 | 0 |
| K073706 | RESPIRATORY HUMIDIFIER, MODEL MR850 | Fisher & Paykel Healthcare, Ltd. | 2008-03-31 | 91 | 0 |
| K063036 | OPUS HC482 DIRECT NASAL MASK | Fisher & Paykel Healthcare, Ltd. | 2006-12-22 | 80 | 0 |
| K061236 | FLEXIFIT HC432 FULL FACE MASK | Fisher & Paykel Healthcare, Ltd. | 2006-08-29 | 118 | 0 |
| K060044 | ACUTE CARE FACE MASK, MODEL RT040 | Fisher & Paykel Healthcare, Ltd. | 2006-04-06 | 90 | 0 |
| K050927 | RT019 INSPIRATORY/EXPIRATORY FILTER | Fisher & Paykel Healthcare, Ltd. | 2005-08-01 | 110 | 0 |
| K050904 | CPAP HUMIDIFIER, MODEL HC238JHU | Fisher & Paykel Healthcare, Ltd. | 2005-05-25 | 44 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda