Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Avery Dennison Belgie Bvba — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
157 daysmedian FDA review time
358 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K202208 | BeneHold Surgical Incise Drape with CHG antimicrobial | Avery Dennison Belgie Bvba | 2021-07-30 | 358 | 0 |
| K170407 | BD ChloraShield IV Dressing with CHG Antimicrobial | Avery Dennison Belgie Bvba | 2017-07-17 | 157 | 0 |
| K152923 | BD ChloraShield IV Dressing with CHG Antimicrobial | Avery Dennison Belgie Bvba | 2015-11-05 | 31 | 0 |
| K133764 | CHLORASHIELD IV DRESSING WITH CHG ANTIMICROBIAL | Avery Dennison Belgie Bvba | 2014-03-13 | 92 | 0 |
| K113836 | BENEHOLD CHG TRANSPARENT FILM DRESSING (10X12CM) (8.5X12CM) | Avery Dennison Belgie Bvba | 2012-09-24 | 271 | 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