Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Carilex Medical, Inc. · 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) |
|---|---|---|---|---|---|
| K231646 | Carilex VT¿200-i NX | Carilex Medical, Inc. | 2024-04-17 | 317 | 0 |
| K173407 | VT - 100, VT - 200 | Carilex Medical, Inc. | 2018-08-09 | 281 | 0 |
| K172725 | VT Dressing Kits | Carilex Medical, Inc. | 2018-06-08 | 270 | 0 |
| K161410 | VT·One, VT·One 60days | Carilex Medical, Inc. | 2016-10-13 | 146 | 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