Vista/Kidsa
Vista/Kidsa Cushion SML
18manufacturers in China registered for this device type
1catalogue number
97510(k) clearances naming this product code
9recalls 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 | Resmed PTY Ltd., Australia |
|---|---|
| FDA product code | BZD |
| Device type | Ventilator, Non-Continuous (Respirator) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5905 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer |
| Record published | 2016-09-16 |
| Record revised | 2023-07-31 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
| Storage | Storage environment humidity 0 to 95 % RH; Storage environment temperature -4 to 140 °F |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 60013 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DreamStation | Respironics Inc. | 386 |
| DreamWear | Respironics Inc. | 183 |
| REMstar System One 60 Series | Respironics Inc. | 163 |
| Fisher & Paykel Healthcare | Fisher & Paykel Healthcare, Ltd. | 152 |
| 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 |
Showing 12 of 699. All products under Ventilator, Non-Continuous (Respirator)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253553 | 2026-06-04 |
| K254104 | 2026-05-27 |
| K251657 | 2025-12-05 |
| K250624 | 2025-05-28 |
| K242547 | 2025-05-19 |
| K241939 | 2024-09-27 |
| K241216 | 2024-09-26 |
| K200565 | 2021-01-17 |
| K203126 | 2020-12-18 |
| K183512 | 2019-05-07 |
| K180497 | 2018-06-15 |
| K170924 | 2018-01-03 |
| K171212 | 2017-09-28 |
| K160836 | 2016-12-15 |
| K161978 | 2016-11-17 |
| K160822 | 2016-09-09 |
| K153563 | 2016-05-13 |
| K153673 | 2016-05-02 |
| K143603 | 2015-05-21 |
| K140279 | 2014-07-31 |
| K140159 | 2014-06-17 |
| K132901 | 2014-06-09 |
| K140054 | 2014-05-16 |
| K140124 | 2014-05-12 |
| K132606 | 2014-01-13 |
| K132887 | 2013-12-20 |
| K132013 | 2013-10-21 |
| K123789 | 2013-03-29 |
| K123979 | 2013-02-27 |
| K121705 | 2012-10-23 |
| K113801 | 2012-05-25 |
| K113780 | 2012-04-20 |
| K113127 | 2012-01-06 |
| K112489 | 2011-12-07 |
| K112393 | 2011-11-16 |
| K111148 | 2011-06-30 |
| K102586 | 2011-03-18 |
| K110444 | 2011-03-16 |
| K102513 | 2011-01-05 |
| K102746 | 2010-12-28 |
| K102224 | 2010-12-10 |
| K100772 | 2010-06-09 |
| K093684 | 2010-02-26 |
| K092026 | 2009-10-02 |
| K091947 | 2009-09-28 |
| K091129 | 2009-08-03 |
| K090490 | 2009-05-06 |
| K090244 | 2009-04-13 |
| K083816 | 2009-03-20 |
| K082605 | 2009-01-13 |
| K082983 | 2009-01-02 |
| K082979 | 2009-01-02 |
| K081321 | 2008-10-09 |
| K080079 | 2008-04-08 |
| K080131 | 2008-04-01 |
| K073638 | 2008-03-20 |
| K072615 | 2008-01-04 |
| K072940 | 2007-12-13 |
| K071808 | 2007-10-10 |
| K070746 | 2007-07-13 |
| K071171 | 2007-07-10 |
| K063011 | 2007-02-02 |
| K063122 | 2007-02-02 |
| K062291 | 2006-09-08 |
| K061200 | 2006-07-20 |
| K053205 | 2006-02-03 |
| K051314 | 2005-07-15 |
| K050775 | 2005-05-10 |
| K050359 | 2005-03-16 |
| K050142 | 2005-03-01 |
| K042403 | 2004-10-08 |
| K041362 | 2004-07-15 |
| K041209 | 2004-07-01 |
| K040944 | 2004-06-03 |
| K034033 | 2004-05-05 |
| K033914 | 2004-04-22 |
| K040566 | 2004-04-02 |
| K033841 | 2004-03-10 |
| K030797 | 2004-03-10 |
| K032916 | 2003-12-04 |
| K032433 | 2003-10-24 |
| K032480 | 2003-10-16 |
| K031047 | 2003-08-19 |
| K030843 | 2003-08-15 |
| K024191 | 2003-07-02 |
| K030798 | 2003-04-09 |
| K023306 | 2002-11-27 |
| K023244 | 2002-11-27 |
| K023284 | 2002-11-27 |
| K013843 | 2002-07-16 |
| K013909 | 2002-07-08 |
| K984428 | 1999-07-26 |
| K982530 | 1998-10-16 |
| K980721 | 1998-09-01 |
| K970771 | 1997-06-20 |
| K970516 | 1997-05-09 |
| K961783 | 1996-08-01 |
Recalls
7 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. 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 |
|---|---|---|---|---|---|
| 2023-11-20 | Class I | Device Design | Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that interact with magnets, and metallic implants/objects containing ferromagnetic material | 199,796 | |
| 2023-11-20 | Class I | Device Design | Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that interact with magnets, and metallic implants/objects containing ferromagnetic material | 2,037,323 | |
| 2023-11-20 | Class I | Device Design | Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that interact with magnets, and metallic implants/objects containing ferromagnetic material | 2,660,776 | |
| 2023-11-20 | Class I | Device Design | Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that interact with magnets, and metallic implants/objects containing ferromagnetic material | 11,885,039 | |
| 2023-11-20 | Class I | Device Design | Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that interact with magnets, and metallic implants/objects containing ferromagnetic material | 3,816,138 | |
| 2023-11-20 | Class I | Device Design | Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that interact with magnets, and metallic implants/objects containing ferromagnetic material | 7,724,968 | |
| 2023-11-20 | Class I | Device Design | Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that interact with magnets, and metallic implants/objects containing ferromagnetic material | 424,309 | |
| 2016-07-12 | Class II | Packaging process control | Masks in this lot, labelled and sold as 62702 vented Quattro Air FFM size Medium actually contain a non-vented (NV) Quattro Air FFM Large mask. | 42 units | 2016-09-26 |
| 2007-04-23 | Not classified | Other | S8 devices manufactured between July 2004 and May 15, 2006 are susceptible to fatigue in the connection of the AC appliance inlet connector and the power supply (power cord) leading to possible failure (short circuit, electrical failure, sp | 300,000 | 2010-12-06 |
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.