Data / Medical devices / United States / Clearflow, Inc
Clearflow, Inc: FDA-registered device maker in Irvine, CA, United States, 4 510(k) clearances
Clearflow, Inc is registered with the FDA (registration 3008782989) in Irvine, CA, United States. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated March 2, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008782989
- Address
- 16 Technology Drive. Suite 150, Irvine, CA, United States, 92618
- Owner or operator
- ClearFlow, Inc. (10034650)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- June 16, 2016
- Registered through
- 2026
- Brand names listed
- PleuraFlow System with FlowGlide 20FR SEDL, PF-20 SEDL, PleuraFlow System with FlowGlide 20FR XDL, PFFG3-20 XDL, PleuraFlow System with FlowGlide 20FR, PFFG-20, PleuraFlow System with FlowGlide 20FR, PFFG3-20, PleuraFlow System with FlowGlide 24FR XDL, PFFG-24 XDL, PleuraFlow System with FlowGlide 24FR XDL, PFFG3-24 XDL, PleuraFlow System with FlowGlide 24FR, PFFG-24, PleuraFlow System with FlowGlide 24FR, PFFG3-24 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Irrigation | GBX | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Wound Drain Catheter System | OTK | 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 2, 2021 | K203394 | PleuraFlow System with FlowGlide | OTK | Substantially Equivalent | Clearflow, Inc. | accessdata.fda.gov |
| August 14, 2018 | K182067 | PleuraFlow System with FlowGlide Extra Drainage Length | OTK | Substantially Equivalent | Clearflow, Inc. | accessdata.fda.gov |
| November 30, 2016 | K163139 | PleuraFlow System with FlowGlide | OTK | Substantially Equivalent | Clearflow, Inc. | accessdata.fda.gov |
| January 20, 2016 | K153681 | PleuraFlow System | OTK | Substantially Equivalent | Clearflow, Inc. | accessdata.fda.gov |
Compare with other makers
Updated March 2, 2021. 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.