Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
OTK — Predicate Candidate Screening
7 FDA 510(k) clearances under this product code; the 50 most recent screened below.
29 daysmedian FDA review time
380 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K203394 | PleuraFlow System with FlowGlide | Clearflow, Inc. | 2021-03-02 | 104 | 0 |
| K191733 | The ZIP Accessory Shuttle for PleuraFlow System | Clearflow, Inc. | 2019-07-26 | 28 | 0 |
| K182067 | PleuraFlow System with FlowGlide Extra Drainage Length | Clearflow, Inc. | 2018-08-14 | 13 | 0 |
| K163139 | PleuraFlow System with FlowGlide | Clearflow, Inc. | 2016-11-30 | 21 | 0 |
| K153681 | PleuraFlow System | Clearflow, Inc. | 2016-01-20 | 29 | 0 |
| K150042 | PleuraFlow System | Clearflow, Inc. | 2015-06-02 | 144 | 0 |
| K093565 | PLEURAFLOW CATHETER SYSTEM | Clear Catheter Systems | 2010-12-03 | 380 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda