Fisher & Paykel Healthcare
F&P Evora Nasal Mask - Fit Pack S/M/L SL For Positive Airway Pressure Therapy
18manufacturers in China registered for this device type
152catalogue numbers in this listing
30510(k) clearances naming this product code
7recalls on this code
Who Else Makes It
Concentrated in Guangdong (8), Jiangsu (2), Zhejiang (2). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GaleMed (Xiamen) Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 33 |
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Suzhou Avon Textile Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 12 |
| Mehow Innovative (Huizhou) Ltd. | Huizhou | Guangdong | Contract manufacturer | 11 |
| Respironics Medical Products (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Hunan Beyond Medical Technology Co., Ltd. | Changsha | Hunan | Contract manufacturer | 3 |
| Shanghai Baron Technologies Co Ltd | Shanghai | Shanghai | Contract manufacturer | 3 |
| BMC(Dongguan) Medical Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 2 |
| Zhejiang Baron Technologies Co., Ltd. | Pinghu | Zhejiang | Contract manufacturer | 1 |
| Modern Medical Equipment Manufacturing (Qing Yuan) Ltd | Qing Yuan | Guangdong | Contract manufacturer | 26 |
| Shenzhen Sany Pioneer Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 9 |
| Resvent Medical Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
Showing 12 of 18. All 18 manufacturers in China registered for Ventilator, Non-Continuous (Respirator)
Record
| Listed by | Fisher & Paykel Healthcare, Ltd., New Zealand |
|---|---|
| FDA product code | BZD |
| Device type | Ventilator, Non-Continuous (Respirator) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5905 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K083832 |
| Record published | 2016-09-08 |
| Record revised | 2022-11-28 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Hydrogen Peroxide |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature -20 to 60 °C |
| Packaging | Pack of 10, box of 10, pack of 5, pack of 60, box of 40 |
| Distribution end date | 2026-04-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 400445SL | In distribution | |
| EVF1MSLA | SMALL-MEDIUM | In distribution |
| SLP1MSLA | MEDIUM | In distribution |
| HC482A | In distribution | |
| Infosmart_web | In distribution | |
| 400451 | Large | In distribution |
| 900HC522 | In distribution | |
| BRE1SMU | Extra Small – Small / Medium – Large | In distribution |
| BRE1SA | Extra Small – Small | In distribution |
| 400470SL | Small | In distribution |
| EVO1WSL | Wide | In distribution |
| EVF1LA | LARGE | In distribution |
| 900ICON208 | In distribution | |
| HC244JHU | In distribution | |
| HC482SL | In distribution | |
| 400470A | Small | In distribution |
| ESN2SA | Small | In distribution |
| EVF1XMLSLA | EXTRA SMALL/SMALL-MEDIUM/LARGE | In distribution |
| NVP1SMLA | In distribution | |
| 900SPS100 | In distribution | |
| 400449 | Small | In distribution |
| EVF1LLA | LARGE-LARGE | In distribution |
| SLN1SMLSLA | SMALL/ MEDIUM/ LARGE | In distribution |
| VIT1MEDA | LARGE | In distribution |
| EVF1LSLA | LARGE | In distribution |
| BRE1MU | Medium – Large | In distribution |
| VIT1SSL | SMALL | In distribution |
| SLN1SA | SMALL | In distribution |
| 400480 | Medium / Medium | In distribution |
| BC163-10 | In distribution | |
| 400475 | Small | In distribution |
| BC153-10 | In distribution | |
| HC432AS | Small | In distribution |
| 400450 | Medium | In distribution |
| 400473SL | Extra Large | In distribution |
| BC171-10 | In distribution | |
| 400471A | Medium/Large | In distribution |
| HC385S | In distribution | |
| NVP1SA | In distribution | |
| 900SPS121 | In distribution | |
| VIT1SEDA | SMALL | In distribution |
| 400446A | In distribution | |
| ICONNAN-HT | In distribution | |
| SLN1SMLA | SMALL/ MEDIUM/ LARGE | In distribution |
| HC234JHU | In distribution | |
| SLP1SA | SMALL | In distribution |
| SLN1SSLA | SMALL | In distribution |
| NVP1LSLA | In distribution | |
| 400451SL | Large | In distribution |
| 400440A | In distribution | |
| ESN2SSL | Small | In distribution |
| EVO1LA | LARGE | In distribution |
| SLP1LSLA | LARGE | In distribution |
| 400477 | Large | In distribution |
| 400421 | In distribution | |
| SLN1WA | WIDE | In distribution |
| HC432AM | Medium | In distribution |
| EVO1WA | WIDE | In distribution |
| 400444SL | In distribution | |
| ICONAAN-HT | In distribution | |
| VIT1SSA | SMALL | In distribution |
| EVF1MA | SMALL-MEDIUM | In distribution |
| EVF1XA | EXTRA SMALL | In distribution |
| BRE1MA | Medium – Large | In distribution |
| SLN1MA | MEDIUM | In distribution |
| BRE1SMA | Extra Small – Small / Medium – Large | In distribution |
| SLP1MA | MEDIUM | In distribution |
| ICONAAN | In distribution | |
| SPSABU | In distribution | |
| 400479 | Small / Small | In distribution |
| NVP1MSLA | In distribution | |
| 400445A | In distribution | |
| BRE1SMSL | Extra Small – Small / Medium – Large | In distribution |
| VIT1MMA | Medium / Medium | In distribution |
| 400446SL | In distribution | |
| 400481 | Large / Large | In distribution |
| EVF1MMA | SMALL-MEDIUM/SMALL-MEDIUM | In distribution |
| HC242JHU | In distribution | |
| 400439SL | In distribution | |
| SLN1LA | LARGE | In distribution |
| ICONNAN | In distribution | |
| 950N62J | In distribution | |
| EVO1MSL | MEDIUM | In distribution |
| BC151-10 | In distribution | |
| 400439A | In distribution | |
| HC355 | In distribution | |
| SLP1SMLA | SMALL/ MEDIUM/ LARGE | In distribution |
| BC161-10 | In distribution | |
| HC431A | In distribution | |
| SLN1WSLA | WIDE | In distribution |
| 400441SL | In distribution | |
| 950N60J | In distribution | |
| NVP1MA | In distribution | |
| 900HC452 | In distribution | |
| BC173-10 | In distribution | |
| VIT1MA | MEDIUM | In distribution |
| EVF1XMLA | EXTRA SMALL/SMALL-MEDIUM/LARGE | In distribution |
| EVF1XXA | D469038 | In distribution |
| ESN2SML | Small/ Medium/ Large | In distribution |
| NVP1SSLA | In distribution | |
| VIT1LEDA | LARGE | In distribution |
| 400476SL | Medium | In distribution |
| VIT1MLSL | Medium / Large | In distribution |
| EVO1SMLSL | SMALL/MEDIUM/LARGE | In distribution |
| HC432AL | Large | In distribution |
| 400471SL | Medium/Large | In distribution |
| 400444A | In distribution | |
| HC452A | In distribution | |
| 400421SL | In distribution | |
| EVO1SSL | SMALL | In distribution |
| 400477SL | Large | In distribution |
| 900ICON205 | In distribution | |
| ESN2LSL | Large | In distribution |
| 400449SL | Small | In distribution |
| EVO1LSL | LARGE | In distribution |
| 900ICON500N | In distribution | |
| ESN2MSL | Medium | In distribution |
| 400450SL | Medium | In distribution |
| EVF1XSLA | EXTRA SMALL | In distribution |
| HC365S | In distribution | |
| EVO1MA | MEDIUM | In distribution |
| HC432AXL | Extra Large | In distribution |
| HC360 | In distribution | |
| 900ICON202 | In distribution | |
| 400483FITPACK | Small/ Medium/ Large | In distribution |
| 900SW100 | In distribution | |
| 400476 | Medium | In distribution |
| SLP1LA | LARGE | In distribution |
| BRE1SU | Extra Small – Small | In distribution |
| ICONPBN | In distribution | |
| 400440SL | In distribution | |
| ESN2LA | Large | In distribution |
| 400473A | Extra Large | In distribution |
| NVP1LA | In distribution | |
| SLP1SSLA | SMALL SMALL | In distribution |
| SLP1SMLSLA | SMALL/ MEDIUM/ LARGE | In distribution |
| 400475SL | Small | In distribution |
| VIT1MSL | MEDIUM | In distribution |
| SPSAAU | In distribution | |
| EVO1SMLA | SMALL/ MEDIUM/ LARGE | In distribution |
| ICONPBN-HT | In distribution | |
| VIT1SA | SMALL | In distribution |
| VIT1LA | Large | In distribution |
| 400441A | In distribution | |
| EVO1SA | SMALL | In distribution |
| ESN2MA | Medium | In distribution |
| 900ICON200 | In distribution | |
| NVP1SMLSLA | In distribution | |
| 900SPS120 | In distribution | |
| VIT1LSL | Large | In distribution |
| SLN1MSLA | MEDIUM | In distribution |
| 900HC611 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DreamStation | Respironics Inc. | 386 |
| DreamWear | Respironics Inc. | 183 |
| REMstar System One 60 Series | Respironics Inc. | 163 |
| DeVilbiss | DeVilbiss Healthcare LLC. | 136 |
| Ventilator, Non-Continuous (Respirator) | Hans Rudolph, Inc. | 115 |
| BiPAP System One 60 Series | Respironics Inc. | 105 |
| Ventilator, Non-Continuous (Respirator) | Salter Labs | 85 |
| BiTrac Select | Pulmodyne Inc. | 79 |
| Yuwell Sleep Apnea Breathing Therapy Mask | Suzhou Yuyue Medical Technology Co., Ltd. | 76 |
| AF541 | Respironics Inc. | 71 |
| CPAP Masks | Sunset Healthcare Solutions, Inc. | 69 |
| Hudson RCI | Teleflex Medical LLC | 69 |
Showing 12 of 699. All products under Ventilator, Non-Continuous (Respirator)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K243583 | 2025-06-18 |
| K221436 | 2023-06-29 |
| K223696 | 2023-05-17 |
| K212371 | 2022-03-18 |
| K200089 | 2020-06-02 |
| K190713 | 2019-10-11 |
| K173193 | 2018-08-08 |
| K161686 | 2017-01-24 |
| K161412 | 2017-01-18 |
| K153505 | 2016-09-20 |
| K130328 | 2013-06-05 |
| K121597 | 2012-10-02 |
| K120027 | 2012-02-23 |
| K110316 | 2011-08-19 |
| K103786 | 2011-03-24 |
| K100011 | 2010-10-08 |
| K094040 | 2010-04-27 |
| K083832 | 2009-03-16 |
| K081029 | 2008-09-12 |
| K080209 | 2008-09-12 |
| K063036 | 2006-12-22 |
| K061236 | 2006-08-29 |
| K050904 | 2005-05-25 |
| K041900 | 2004-08-31 |
| K040941 | 2004-06-10 |
| K040506 | 2004-05-05 |
| K033087 | 2004-01-14 |
| K023670 | 2003-06-12 |
| K023559 | 2003-06-12 |
| K003894 | 2001-06-25 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2013-04-22 | Class II | Nonconforming Material/Component | Fisher and Paykel Healthcare is recalling the ICON CPAP units because there is a potential power issue on certain ICON CPAP. These ICON CPAP units could potentially become inoperable, which would result in a lack of treatment to the patien | 1,407 units | 2013-10-18 |
| 2006-11-24 | Not classified | Other | Plastic tabs incorporated into the connector components of these CPAP masks may break off if they are not cleaned in accordance with the Instructions for Use. In the event of a tab breaking off, it may enter the CPAP system air path and the | 815,239 total for all models, all lots | 2012-03-26 |
| 2006-11-24 | Not classified | Other | Plastic tabs incorporated into the connector components of these CPAP masks may break off if they are not cleaned in accordance with the Instructions for Use. In the event of a tab breaking off, it may enter the CPAP system air path and the | 815,239 total for all models, all lots | 2012-03-26 |
| 2006-11-24 | Not classified | Other | Plastic tabs incorporated into the connector components of these CPAP masks may break off if they are not cleaned in accordance with the Instructions for Use. In the event of a tab breaking off, it may enter the CPAP system air path and the | 815,239 total for all models, all lots | 2012-03-26 |
| 2006-11-24 | Not classified | Other | Plastic tabs incorporated into the connector components of these CPAP masks may break off if they are not cleaned in accordance with the Instructions for Use. In the event of a tab breaking off, it may enter the CPAP system air path and the | 815,239 total for all models, all lots | 2012-03-26 |
| 2006-11-24 | Not classified | Other | Plastic tabs incorporated into the connector components of these CPAP masks may break off if they are not cleaned in accordance with the Instructions for Use. In the event of a tab breaking off, it may enter the CPAP system air path and the | 815,239 total for all models, all lots | 2012-03-26 |
| 2006-11-24 | Not classified | Other | Plastic tabs incorporated into the connector components of these CPAP masks may break off if they are not cleaned in accordance with the Instructions for Use. In the event of a tab breaking off, it may enter the CPAP system air path and the | 815,239 total for all models, all lots | 2012-03-26 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.