Data / Medical devices / United States / Potrero Medical, Inc.
Potrero Medical, Inc.: FDA-registered device maker in Hayward, CA, United States, 2 510(k) clearances
Potrero Medical, Inc. is registered with the FDA (registration 3011383638) in Hayward, CA, United States. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated January 13, 2023. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3011383638
- Address
- 26142 Eden Landing Road, Hayward, CA, United States, 94545
- Owner or operator
- Potrero Medical, Inc. (10050934)
- Roles
- Manufacturer
- First device listed
- November 21, 2016
- Registered through
- 2026
- Brand names listed
- AccuTab, Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System, Accuryn SmartFoley UO Temp Tray System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Retention Type, Balloon | EZL | 2 | Manufacturer | accessdata.fda.gov |
| Intra-Abdominal Pressure Monitoring Device | PHU | U | Manufacturer | accessdata.fda.gov |
| Medical Device Data System | OUG | 1 | Manufacturer | accessdata.fda.gov |
| Uroflowmeter | EXY | 2 | Manufacturer | 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 13, 2023 | K221020 | Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F, Accuryn SmartFoley IAP UO Temp Tray System 14 F | EZL | Unknown | Potrero Medical, Inc. | accessdata.fda.gov |
| April 15, 2016 | K153655 | Accuryn Monitoring System | EZL | Unknown | Potrero Medical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Intra-Abdominal Pressure Monitoring Device
- All makers of Uroflowmeter
- All makers of Medical Device Data System
- All makers of Catheter, Retention Type, Balloon
Updated January 13, 2023. 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.