Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
ONQ · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K210077 | MED RF 4000 | F Care Systems USA, LLC | 2021-12-17 | 339 | 0 |
| K130283 | EVRF SYSTEM | F Care Systems NV | 2013-03-07 | 30 | 0 |
| K112334 | VEIN-GOGH INSTRUMENT | Refine USA, LLC | 2012-05-08 | 270 | 0 |
| K083352 | VEINWAVE, TC3000 | Newlands Clinical Trials, Ltd. | 2009-06-12 | 211 | 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