Data / Medical devices / United States / Bright Uro, Inc.
Bright Uro, Inc.: FDA-registered device maker in Irvine, CA, United States, 2 510(k) clearances
Bright Uro, Inc. is registered with the FDA (registration 3029753827) in Irvine, CA, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 16, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3029753827
- Address
- 3 Goddard, Irvine, CA, United States, 92618
- Owner or operator
- Bright Uro, Inc. (10093586)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- June 9, 2025
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cystometer, Electrical Recording | EXQ | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Uroflowmeter | EXY | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, 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 |
|---|---|---|---|---|---|---|
| April 16, 2026 | K253537 | Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics System Female Delivery System (GUS-1000-F); Glean Urodynamics System Uroflowmeter (UFM-1000 (Uroflowmeter)); Glean Urodynamics System Abdominal Sensor (GUS-1000-A) | EXQ | Substantially Equivalent | Bright Uro, Inc. | accessdata.fda.gov |
| March 24, 2025 | K243052 | Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics System Female Delivery System (GUS-1000-F); Glean Urodynamics System Uroflowmeter (UFM-1000 (Uroflowmeter)) | EXQ | Substantially Equivalent | Bright Uro, Inc. | accessdata.fda.gov |
Compare with other makers
Updated April 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.