Lumis
AirCurve 10 ST-A 3G CO
6manufacturers in China registered for this device type
1catalogue number
19510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (4), Beijing (1), Tianjin (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Respironics Medical Products (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| BMC (Tianjin) Medical Co., Ltd. | Wuqing District | Tianjin | Contract manufacturer | 3 |
| Huizhou RSP Technology Co., Ltd. | Huizhou | Guangdong | Contract manufacturer | 3 |
| Modern Medical Equipment Manufacturing (Qing Yuan) Ltd | Qing Yuan | Guangdong | Contract manufacturer | 26 |
| BMC Medical Co., Ltd. | Fengtai District | Beijing | Specification developer | 3 |
Record
| Listed by | Resmed PTY Ltd., Australia |
|---|---|
| FDA product code | MNS |
| Device type | Ventilator, Continuous, Non-Life-Supporting |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5895 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer |
| Record published | 2016-09-26 |
| Record revised | 2023-06-27 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, serial number |
| Storage | Storage environment atmospheric pressure 70 to 106 KiloPascal; Storage environment humidity 5 to 95 % RH; Storage environment temperature -4 to 140 °F |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 150 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DreamStation | Respironics Inc. | 144 |
| AF531 | Respironics Inc. | 53 |
| BiPAP autoSV Advanced System One 60 Series | Respironics Inc. | 44 |
| BiPAP Avaps | Respironics Inc. | 35 |
| DreamStation BiPAP Avaps | Respironics Inc. | 30 |
| DreamMapper | Respironics Inc. | 27 |
| BiPAP A30 | Respironics Inc. | 25 |
| BiPAP S/T C-Series | Respironics Inc. | 19 |
| OmniLab Advanced Plus | Respironics Inc. | 19 |
| EncoreAnywhere | Respironics Inc. | 17 |
| DeVilbiss | DeVilbiss Healthcare LLC. | 15 |
| Ventilator, Continuous, Non-Life-Supporting | Salter Labs | 12 |
Showing 12 of 73. All products under Ventilator, Continuous, Non-Life-Supporting
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K251889 | 2026-04-08 |
| K251661 | 2026-02-23 |
| K161492 | 2017-01-19 |
| K161487 | 2016-09-09 |
| K153061 | 2016-04-13 |
| K132371 | 2013-11-22 |
| K123511 | 2013-03-21 |
| K123557 | 2013-03-14 |
| K122324 | 2012-11-13 |
| K113714 | 2012-05-25 |
| K113288 | 2012-03-29 |
| K113815 | 2012-03-27 |
| K112914 | 2011-12-29 |
| K093731 | 2010-03-22 |
| K092186 | 2009-12-22 |
| K060105 | 2006-04-07 |
| K051364 | 2005-08-16 |
| K033276 | 2004-06-07 |
| K974417 | 1998-06-24 |
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.