Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Flow-Fx, LLC — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K234075 | Flow-Nail | Flow-Fx, LLC | 2024-02-05 | 26 | 0 |
| K221115 | Flow-Nail | Flow-Fx, LLC | 2022-05-13 | 28 | 0 |
| K142776 | Flow-Screw | Flow-Fx, LLC | 2015-03-23 | 178 | 0 |
| K140601 | FLOW-NAIL | Flow-Fx, LLC | 2014-07-02 | 114 | 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