Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Aln Implants Chirurgicaux · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K163699 | ALN Optional Vena Cava Filter - Femoral Approach, ALN Option | Aln Implants Chirurgicaux | 2017-09-08 | 253 | 0 |
| K113124 | ALN OPTIONAL VANA CAVA FILTER | Aln Implants Chirurgicaux | 2012-11-09 | 385 | 0 |
| K070514 | ALN OPTIONAL VENA CAVA FILTER-FEMORAL APPROACH, JUGULAR APPR | Aln Implants Chirurgicaux | 2008-01-30 | 342 | 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