Data / Medical devices / United States / Rasimo Systems LLC
Rasimo Systems LLC: FDA-registered device maker in Raleigh, NC, United States, 1 510(k) clearance
Rasimo Systems LLC is registered with the FDA (registration 3042026207) in Raleigh, NC, United States. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 10, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3042026207
- Address
- 4801 Glenwood Ave Ste 200, Raleigh, NC, United States, 27612
- Owner or operator
- Rasimo Systems LLC (10094074)
- Roles
- Specification developer
- First device listed
- November 17, 2025
- Registered through
- 2026
- Brand names listed
- SureMediks Beta-Ketone Test Strips, SureMediks Blood Glucose Test Strips, SureMediks Keto-Pro Plus
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Glucose Dehydrogenase, Glucose | LFR | 2 | Specification developer | accessdata.fda.gov |
| Nitroprusside, Ketones (Urinary, Non-Quant.) | JIN | 1 | Specification developer | accessdata.fda.gov |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | 1 | Specification developer | accessdata.fda.gov |
| System, Test, Blood Glucose, Over The Counter | NBW | 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 |
|---|---|---|---|---|---|---|
| November 10, 2016 | K161738 | FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Monitoring Systems | NBW | Substantially Equivalent | Taidoc Technology Corporation | accessdata.fda.gov |
Compare with other makers
- All makers of System, Test, Blood Glucose, Over The Counter
- All makers of Glucose Dehydrogenase, Glucose
- All makers of Single (Specified) Analyte Controls (Assayed And Unassayed)
- All makers of Nitroprusside, Ketones (Urinary, Non-Quant.)
Updated November 10, 2016. 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.