FitStar Full Face Vented Mask, Small
Catalogue number 10700, listed by Sleepnet Corporation, United States, under Ventilator, Non-Continuous (Respirator). 18 manufacturers in China are registered for this product code.
18manufacturers in China registered for this device type
1catalogue number
18510(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 | Sleepnet Corporation, United States |
|---|---|
| FDA product code | BZD |
| Device type | Ventilator, Non-Continuous (Respirator) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5905 |
| Establishment | Manufacturer, Exporter |
| Record published | 2022-01-11 |
| Record revised | 2023-08-03 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature up to 140 °F |
| Packaging | Case of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10700 | 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 |
|---|---|
| K251847 | 2026-01-15 |
| K241830 | 2024-10-18 |
| K241661 | 2024-07-10 |
| K241469 | 2024-06-15 |
| K211274 | 2022-01-10 |
| K203601 | 2021-04-30 |
| K190254 | 2019-07-05 |
| K121321 | 2012-11-30 |
| K121692 | 2012-11-05 |
| K120463 | 2012-07-27 |
| K102317 | 2011-05-17 |
| K090935 | 2009-07-01 |
| K060273 | 2006-05-02 |
| K021534 | 2002-07-02 |
| K013306 | 2001-11-02 |
| K993269 | 1999-10-27 |
| K962713 | 1996-10-23 |
| K953697 | 1996-06-13 |
Recalls
7 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2024-03-01 | Class I | Device Design | Update to contraindications and warning language due to CPAP masks containing magnets. | 23,042 units |
| 2024-03-01 | Class I | Device Design | Update to contraindications and warning language due to CPAP masks containing magnets. | 1,268 units |
| 2024-03-01 | Class I | Device Design | Update to contraindications and warning language due to CPAP masks containing magnets. | 2477 units |
| 2024-03-01 | Class I | Device Design | Update to contraindications and warning language due to CPAP masks containing magnets. | 2,787 units |
| 2024-03-01 | Class I | Device Design | Update to contraindications and warning language due to CPAP masks containing magnets. | 2,107 units |
| 2024-03-01 | Class I | Device Design | Update to contraindications and warning language due to CPAP masks containing magnets. | 2417 units |
| 2024-03-01 | Class I | Device Design | Update to contraindications and warning language due to CPAP masks containing magnets. | 11,874 units |
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.