Data / Medical devices / United States / Carda Health
Carda Health: FDA-registered device maker in Houston, TX, United States, 6 510(k) clearances
Carda Health is registered with the FDA (registration 3038878471) in Houston, TX, United States. It lists 2 device types. The FDA files 6 510(k) clearances under its listings, the newest dated February 28, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3038878471
- Address
- 10795 Hammerly Blvd Ste H11, Houston, TX, United States, 77043
- Owner or operator
- Carda Health (10093463)
- Roles
- Repackager or relabeler
- First device listed
- May 19, 2025
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Oximeter | DQA | 2 | Repackager or relabeler | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| February 28, 2025 | K242876 | Pulse Oximeter ( PO2, PO2A, PO2B) | DQA | Substantially Equivalent | Shenzhen Viatom Technology Co., Ltd. | accessdata.fda.gov |
| October 4, 2024 | K242721 | Upper Arm Electronic Blood Pressure Monitor (FC-BP103, FC-BP106, FC-BP113, FC-BP120, FC-BP121, FC-BP130, FC-BP131) | DXN | Substantially Equivalent | Shenzhen Finicare Co., Ltd. | accessdata.fda.gov |
| April 22, 2016 | K160019 | U80 Series Upper Arm Electronic Blood Pressure Monitor | DXN | Substantially Equivalent | Shenzhen Urion Technology Co., Ltd. | accessdata.fda.gov |
| June 3, 2015 | K150093 | Pulse Oximeter, Models PC-66A; PC-66B; PC-66C;PC-60B1; PC-60B5; PC-60D; PC-60D2; PC-60E; PC-60N; POD-1; POD-2; POD-3; PC-68A; PC-68B; PC-68C; POD- 1W; and POD-60NW-1 | DQA | Substantially Equivalent | Shenzhen Creative Industry Co., Ltd. | accessdata.fda.gov |
| January 16, 2014 | K133379 | HEM-7311 | DXN | Substantially Equivalent | Omron Healthcare, Inc. | accessdata.fda.gov |
| August 2, 2006 | K061822 | OMRON AUTOMATIC BLOOD PRESSURE MONITOR WITH COMFIT CUFF, MODEL HEM 780 N3 | DXN | Substantially Equivalent | Omron Healthcare, Inc. | accessdata.fda.gov |
Compare with other makers
Updated February 28, 2025. 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.