Data / Medical devices / Continuous, Minimal Ventilatory Support, Facility Use Ventilator
Continuous, Minimal Ventilatory Support, Facility Use Ventilator (MNT): 20 FDA-registered makers in 9 countries
20 establishments in 9 countries are registered with the FDA to make Continuous, Minimal Ventilatory Support, Facility Use Ventilator (product code MNT, Class 2, 21 CFR 868.5895). 12 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 25 510(k) clearances under this code, the latest on April 6, 2026, and lists 23 recall events (10 Class I). FDA data exported November 2, 2026.
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- Product code
- MNT
- Device class
- 2
- Regulation
- 868.5895
- Medical specialty
- Anesthesiology
- Life sustaining or supporting
- Yes
Makers by country
| Country | Makers |
|---|---|
| China | 6 |
| United States | 5 |
| India | 2 |
| Sweden | 2 |
| New Zealand | 1 |
| Australia | 1 |
| South Korea | 1 |
| Mexico | 1 |
| United Kingdom | 1 |
Makers of Continuous, Minimal Ventilatory Support, Facility Use Ventilator
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 |
|---|---|---|---|---|---|---|---|---|
| Fisher & Paykel Healthcare, Ltd. | EAST TAMAKI Auckland, New Zealand | Complaint file establishment, Manufacturer | 4 | August 9, 2024 | 0 | 0 | 0 | api.fda.gov |
| Respironics Inc. | Murrysville, PA, United States | Complaint file establishment, Manufacturer, Manufacturer for export, Specification developer | 4 | December 14, 2012 | 0 | 19 | 9 | api.fda.gov |
| Philips Global Business Services LLP | Baner Pune Maharashtra, India | Manufacturer, Specification developer | 3 | December 14, 2012 | 0 | 0 | 0 | api.fda.gov |
| Resmed Corp | San Diego, CA, United States | Complaint file establishment, Manufacturer | 3 | June 17, 2013 | 0 | 0 | 0 | api.fda.gov |
| Resmed Pty Ltd. | BELLA VISTA New South Wales, Australia | Contract manufacturer, Manufacturer | 3 | June 17, 2013 | 0 | 1 | 1 | api.fda.gov |
| Breas Medical AB | MOLNLYCKE Vastra Gotaland, Sweden | Manufacturer | 1 | December 13, 2024 | 0 | 0 | 0 | api.fda.gov |
| Maquet Critical Care AB | SOLNA Stockholm, Sweden | Manufacturer | 1 | July 6, 2023 | 0 | 0 | 0 | api.fda.gov |
| Mekics Co., Ltd. | Paju-si Gyeonggi, South Korea | Manufacturer | 1 | May 15, 2025 | 0 | 0 | 0 | api.fda.gov |
| Nihon Kohden Orangemed, LLC | Santa Ana, CA, United States | Manufacturer, Specification developer | 1 | July 1, 2022 | 0 | 0 | 0 | api.fda.gov |
| Respironics, Inc. | Mount Pleasant, PA, United States | Manufacturer | 1 | December 14, 2012 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 1 | April 6, 2026 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Mindray Bio-Medical Electronics Co.,LTD | SHENZHEN Guangdong, China | Specification developer | 1 | April 6, 2026 | 0 | 0 | 0 | api.fda.gov |
| Fisher & Paykel Healthcare S.A.de C.V. | Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GVS Filter Technology UK Ltd | Lancaster Lancashire, United Kingdom | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GaleMed (Xiamen) Co., Ltd. | XIAMEN Fujian, 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 | |
| Mehow Innovative (huizhou) Ltd. | Huizhou Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MINDRAY DS USA, Inc. | Mahwah, NJ, United States | 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 | |
| Respironics Medical Products (Shenzhen) Co., Ltd. | Shenzhen Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated April 6, 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.