Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Vygon USA — 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) |
|---|---|---|---|---|---|
| K243361 | Nutrifit | Vygon USA | 2024-12-19 | 51 | 0 |
| K212370 | Leaderflex Mini and Leaderflex Nano | Vygon USA | 2022-08-29 | 395 | 0 |
| K181208 | Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Cathet | Vygon USA | 2018-11-02 | 179 | 0 |
| K172899 | Vygon PICCs | Vygon USA | 2018-02-26 | 157 | 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