Data / Medical devices / Accessory To Continuous Ventilator (Respirator)
Accessory To Continuous Ventilator (Respirator) (MOD): 8 FDA-registered makers in 5 countries
8 establishments in 5 countries are registered with the FDA to make Accessory To Continuous Ventilator (Respirator) (product code MOD, Class 2, 21 CFR 868.5895). 8 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 16 510(k) clearances under this code, the latest on August 27, 2026, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- MOD
- Device class
- 2
- Regulation
- 868.5895
- Medical specialty
- Anesthesiology
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| Sweden | 1 |
| United Kingdom | 1 |
| China | 1 |
| Mexico | 1 |
Makers of Accessory To Continuous Ventilator (Respirator)
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 |
|---|---|---|---|---|---|---|---|---|
| Breas Medical AB | MOLNLYCKE Vastra Gotaland, Sweden | Manufacturer | 1 | May 20, 2025 | 0 | 0 | 0 | api.fda.gov |
| Corvent Medical Inc. | Fargo, ND, United States | Manufacturer | 1 | May 12, 2026 | 0 | 0 | 0 | api.fda.gov |
| Covidien | Carlsbad, CA, United States | Complaint file establishment, Specification developer | 1 | March 7, 1995 | 0 | 0 | 0 | api.fda.gov |
| GVS Filter Technology UK Ltd | Lancaster Lancashire, United Kingdom | Manufacturer, Specification developer | 1 | June 3, 2004 | 0 | 0 | 0 | api.fda.gov |
| GVS Technology (Suzhou) Co., Ltd | Suzhou Jiangsu, China | Contract manufacturer, Manufacturer | 1 | June 3, 2004 | 0 | 0 | 0 | api.fda.gov |
| Resmed Corp | San Diego, CA, United States | Complaint file establishment, Manufacturer | 1 | August 27, 2026 | 0 | 0 | 0 | api.fda.gov |
| WESTMED de Mexico, S.A de C.V. | Tecate Baja California, Mexico | Manufacturer | 1 | June 3, 2004 | 0 | 0 | 0 | api.fda.gov |
| Westmed, Inc. | Tucson, AZ, United States | Manufacturer | 1 | June 3, 2004 | 0 | 0 | 0 | api.fda.gov |
Updated August 27, 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.