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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

CountryMakers
United States8
China7
Australia2
India2
Sweden1
Taiwan1
Hong Kong1
Singapore1

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Resmed CorpSan Diego, CA, United StatesComplaint file establishment, Manufacturer10April 8, 2026000api.fda.gov
Resmed Pty Ltd.BELLA VISTA New South Wales, AustraliaContract manufacturer, Manufacturer9February 23, 2026000api.fda.gov
Respironics Inc.Murrysville, PA, United StatesComplaint file establishment, Manufacturer, Manufacturer for export, Specification developer6February 1, 2012096api.fda.gov
Respironics, Inc.Mount Pleasant, PA, United StatesManufacturer3February 1, 2012000api.fda.gov
Philips Global Business Services LLPBaner Pune Maharashtra, IndiaManufacturer, Specification developer2February 1, 2012000api.fda.gov
Respironics, Inc.New Kensington, PA, United StatesManufacturer2January 22, 2010000api.fda.gov
SMD Manufacturing LLCSalt Lake City, UT, United StatesComplaint file establishment, Specification developer2July 13, 2023000api.fda.gov
3B Medical IncW Jefferson, OH, United StatesManufacturer1December 5, 2022000api.fda.gov
BMC (Tianjin) Medical Co., Ltd.Wuqing District Tianjin, ChinaSpecification developer1December 5, 2022000api.fda.gov
BMC Medical Co., Ltd.Fengtai District Beijing, ChinaManufacturer, Specification developer1December 5, 2022011api.fda.gov
Breas Medical ABMOLNLYCKE Vastra Gotaland, SwedenManufacturer1December 13, 2024000api.fda.gov
Compal Electronics, IncTaoyuan City, TaiwanManufacturer1March 17, 2026000api.fda.gov
Salter LabsEl Paso, TX, United StatesComplaint file establishment, Specification developer1January 14, 2004000api.fda.gov
BMC (Tianjin) Medical Co., Ltd.Wuqing District Tianjin, ChinaContract manufacturer0000api.fda.gov
Huizhou RSP Technology Co.,ltdHuizhou Guangdong, ChinaContract manufacturer0000api.fda.gov
Inventus Power, Inc.Dongguan City P.R. Guangdong, ChinaContract manufacturer0000api.fda.gov
Modern Medical Equipment Manufacturing Ltd.HENG LI, DONGGUAN Guangdong, ChinaContract manufacturer0000api.fda.gov
Modern Medical Equipment Manufacturing, Ltd.Kwai Chung, N.T., Hong KongContract manufacturer0000api.fda.gov
Philips India Limited - Sleep & Respiratory Care Business UnitBengaluru Karnataka, IndiaContract manufacturer0000api.fda.gov
ResMed Asia Pte. Ltd.Singapore South West, SingaporeContract manufacturer0000api.fda.gov
ResMed CorpLithia Spgs, GA, United StatesContract manufacturer0000api.fda.gov
Respironics Medical Products (Shenzhen) Co., Ltd.Shenzhen Guangdong, ChinaContract manufacturer0000api.fda.gov
W&S Plastics Pty LtdMoorebank New South Wales, AustraliaContract manufacturer0000api.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.