Data / Medical devices / United States / Carecubes, Inc.
Carecubes, Inc.: FDA-registered device maker in Arden Hills, MN, United States, 1 510(k) clearance
Carecubes, Inc. is registered with the FDA (registration 3038166862) in Arden Hills, MN, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated January 3, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3038166862
- Address
- 4440 Round Lake Rd W, Arden Hills, MN, United States, 55112
- Owner or operator
- Carecubes, Inc. (10092995)
- Roles
- Specification developer
- First device listed
- March 14, 2025
- Registered through
- 2026
- Brand names listed
- Carecube Negative Pressure Isolation Chamber
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Chamber, Patient Isolation | LGM | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 3, 2024 | K231256 | Carecube Negative Pressure Isolation Chamber | LGM | Substantially Equivalent | Carecubes, Inc. | accessdata.fda.gov |
Compare with other makers
Updated January 3, 2024. 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.