Clearflow, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Clearflow, Inc.” (first 2015, latest 2021), across 1 product code in 1 review panel. Median 510(k) review time under this name: 28 days. Since 2017 the median was 28 days, against 28 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2015 | 1 | 144 |
| 2016 | 2 | 25 |
| 2017 | 0 | — |
| 2018 | 1 | 13 |
| 2019 | 1 | 28 |
| 2020 | 0 | — |
| 2021 | 1 | 104 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Clearflow, Inc. took a median 28 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 28 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OTK | Wound Drain Catheter System | 6 | 6 |
Review panels
Most recent Clearflow, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K203394 | PleuraFlow System with FlowGlide | OTK | 2021-03-02 | 104 |
| K191733 | The ZIP Accessory Shuttle for PleuraFlow System | OTK | 2019-07-26 | 28 |
| K182067 | PleuraFlow System with FlowGlide Extra Drainage Length | OTK | 2018-08-14 | 13 |
| K163139 | PleuraFlow System with FlowGlide | OTK | 2016-11-30 | 21 |
| K153681 | PleuraFlow System | OTK | 2016-01-20 | 29 |
| K150042 | PleuraFlow System | OTK | 2015-06-02 | 144 |
Recalls
openFDA lists no recalls under a recalling firm named Clearflow, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Clearflow, Inc. is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT02145858: Prevention of Retained-Blood Outcomes With Active Clearance Technology (Completed, started 2014-06)
Frequently asked questions
How many FDA 510(k) clearances are listed under Clearflow, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Clearflow, Inc.” (first 2015, latest 2021), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Clearflow, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Clearflow, Inc. is 28 days. Since 2017: 28 days, versus 28 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Clearflow, Inc.?
The most frequent FDA product codes under this applicant name are OTK (Wound Drain Catheter System, 6).
Next steps
- See all 6 Clearflow, Inc. clearances with predicates and recalls
- Run predicate analysis for product code OTK, Clearflow, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.