Clearflow, Inc
Irvine, CA, US
CLEARFLOW, INC appears in FDA device records in Irvine, CA. FDA records list 6 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 6 510(k) clearances for Clearflow, Inc between 2015 and 2021. The busiest year on record is 2016, with 2. The most recent is 2021, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2015 | 1 |
| 2016 | 2 |
| 2018 | 1 |
| 2019 | 1 |
| 2021 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K203394 | PleuraFlow System with FlowGlide | OTK | Substantially Equivalent | |
| K191733 | The ZIP Accessory Shuttle for PleuraFlow System | OTK | Substantially Equivalent | |
| K182067 | PleuraFlow System with FlowGlide Extra Drainage Length | OTK | Substantially Equivalent | |
| K163139 | PleuraFlow System with FlowGlide | OTK | Substantially Equivalent | |
| K153681 | PleuraFlow System | OTK | Substantially Equivalent | |
| K150042 | PleuraFlow System | OTK | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3008782989 | 3008782989 | CLEARFLOW, INC | 16 Technology Drive. Suite 150, Irvine, CA 92618 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain