Data / Medical devices / United States / Signos, Inc.
Signos, Inc.: FDA-registered device maker in Laguna Niguel, CA, United States, 1 510(k) clearance
Signos, Inc. is registered with the FDA (registration 3041000794) in Laguna Niguel, CA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated March 21, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3041000794
- Address
- 30011 Ivy Glenn Dr Ste 107, Laguna Niguel, CA, United States, 92677
- Owner or operator
- Signos, Inc. (10094001)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- September 8, 2025
- Registered through
- 2026
- Brand names listed
- Signos, Signos GMS, Signos Glucose Management System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter | SAF | 2 | Complaint file establishment, Manufacturer, 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 |
|---|---|---|---|---|---|---|
| March 21, 2025 | K250106 | Signos Glucose Monitoring System | SAF | Substantially Equivalent | Signos, Inc. | accessdata.fda.gov |
Compare with other makers
Updated March 21, 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.