Data / Medical devices / Ventilator, Continuous, Non-Life-Supporting
Ventilator, Continuous, Non-Life-Supporting (MNS): 23 FDA-registered makers in 8 countries
23 establishments in 8 countries are registered with the FDA to make Ventilator, Continuous, Non-Life-Supporting (product code MNS, Class 2, 21 CFR 868.5895). 13 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 47 510(k) clearances under this code, the latest on April 8, 2026, and lists 10 recall events (7 Class I). FDA data exported November 2, 2026.
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- Product code
- MNS
- Device class
- 2
- Regulation
- 868.5895
- Medical specialty
- Anesthesiology
Makers by country
| Country | Makers |
|---|---|
| United States | 8 |
| China | 7 |
| Australia | 2 |
| India | 2 |
| Sweden | 1 |
| Taiwan | 1 |
| Hong Kong | 1 |
| Singapore | 1 |
Makers of Ventilator, Continuous, Non-Life-Supporting
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Resmed Corp | San Diego, CA, United States | Complaint file establishment, Manufacturer | 10 | April 8, 2026 | 0 | 0 | 0 | api.fda.gov |
| Resmed Pty Ltd. | BELLA VISTA New South Wales, Australia | Contract manufacturer, Manufacturer | 9 | February 23, 2026 | 0 | 0 | 0 | api.fda.gov |
| Respironics Inc. | Murrysville, PA, United States | Complaint file establishment, Manufacturer, Manufacturer for export, Specification developer | 6 | February 1, 2012 | 0 | 9 | 6 | api.fda.gov |
| Respironics, Inc. | Mount Pleasant, PA, United States | Manufacturer | 3 | February 1, 2012 | 0 | 0 | 0 | api.fda.gov |
| Philips Global Business Services LLP | Baner Pune Maharashtra, India | Manufacturer, Specification developer | 2 | February 1, 2012 | 0 | 0 | 0 | api.fda.gov |
| Respironics, Inc. | New Kensington, PA, United States | Manufacturer | 2 | January 22, 2010 | 0 | 0 | 0 | api.fda.gov |
| SMD Manufacturing LLC | Salt Lake City, UT, United States | Complaint file establishment, Specification developer | 2 | July 13, 2023 | 0 | 0 | 0 | api.fda.gov |
| 3B Medical Inc | W Jefferson, OH, United States | Manufacturer | 1 | December 5, 2022 | 0 | 0 | 0 | api.fda.gov |
| BMC (Tianjin) Medical Co., Ltd. | Wuqing District Tianjin, China | Specification developer | 1 | December 5, 2022 | 0 | 0 | 0 | api.fda.gov |
| BMC Medical Co., Ltd. | Fengtai District Beijing, China | Manufacturer, Specification developer | 1 | December 5, 2022 | 0 | 1 | 1 | api.fda.gov |
| Breas Medical AB | MOLNLYCKE Vastra Gotaland, Sweden | Manufacturer | 1 | December 13, 2024 | 0 | 0 | 0 | api.fda.gov |
| Compal Electronics, Inc | Taoyuan City, Taiwan | Manufacturer | 1 | March 17, 2026 | 0 | 0 | 0 | api.fda.gov |
| Salter Labs | El Paso, TX, United States | Complaint file establishment, Specification developer | 1 | January 14, 2004 | 0 | 0 | 0 | api.fda.gov |
| BMC (Tianjin) Medical Co., Ltd. | Wuqing District Tianjin, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Huizhou RSP Technology Co.,ltd | Huizhou Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Inventus Power, Inc. | Dongguan City P.R. Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Modern Medical Equipment Manufacturing Ltd. | HENG LI, DONGGUAN Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Modern Medical Equipment Manufacturing, Ltd. | Kwai Chung, N.T., Hong Kong | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Philips India Limited - Sleep & Respiratory Care Business Unit | Bengaluru Karnataka, India | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ResMed Asia Pte. Ltd. | Singapore South West, Singapore | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ResMed Corp | Lithia Spgs, GA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Respironics Medical Products (Shenzhen) Co., Ltd. | Shenzhen Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| W&S Plastics Pty Ltd | Moorebank New South Wales, Australia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated April 8, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.