Data / Medical devices / Chamber, Patient Isolation
Chamber, Patient Isolation (LGM): 6 FDA-registered makers in 2 countries
6 establishments in 2 countries are registered with the FDA to make Chamber, Patient Isolation (product code LGM, Class 2, 21 CFR 880.5450). 4 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 13 510(k) clearances under this code, the latest on October 16, 2026, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- LGM
- Device class
- 2
- Regulation
- 880.5450
- Medical specialty
- General Hospital
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
| Mexico | 1 |
Makers of Chamber, Patient Isolation
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 |
|---|---|---|---|---|---|---|---|---|
| Carecubes, Inc. | Arden Hills, MN, United States | Specification developer | 1 | January 3, 2024 | 0 | 0 | 0 | api.fda.gov |
| Isovac Products LLC | Romeoville, IL, United States | Manufacturer | 1 | November 2, 2017 | 0 | 0 | 0 | api.fda.gov |
| La Ada de Acuna | CIUDAD DE ACUNA Coahuila, Mexico | Manufacturer | 1 | November 25, 1986 | 0 | 0 | 0 | api.fda.gov |
| O&M Halyard, Inc. | Alpharetta, GA, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | November 25, 1986 | 0 | 0 | 0 | api.fda.gov |
| Mendtronix, Inc. | San Diego, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| TPI Custom Solutions | Ham Lake, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated October 16, 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.