Avery Dennison Belgie Bvba: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Avery Dennison Belgie Bvba” (first 2012, latest 2021), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 157 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 271 |
| 2013 | 0 | — |
| 2014 | 1 | 92 |
| 2015 | 1 | 31 |
| 2016 | 0 | — |
| 2017 | 1 | 157 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 358 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Avery Dennison Belgie Bvba took a median 258 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 232 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FRO | Dressing, Wound, Drug | 4 | 4 |
| KKX | Drape, Surgical, Antimicrobial | 1 | 1 |
Review panels
Most recent Avery Dennison Belgie Bvba 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K202208 | BeneHold Surgical Incise Drape with CHG antimicrobial | KKX | 2021-07-30 | 358 |
| K170407 | BD ChloraShield IV Dressing with CHG Antimicrobial | FRO | 2017-07-17 | 157 |
| K152923 | BD ChloraShield IV Dressing with CHG Antimicrobial | FRO | 2015-11-05 | 31 |
| K133764 | CHLORASHIELD IV DRESSING WITH CHG ANTIMICROBIAL | FRO | 2014-03-13 | 92 |
| K113836 | BENEHOLD CHG TRANSPARENT FILM DRESSING (10X12CM) (8.5X12CM) (6.5X7 CM) | FRO | 2012-09-24 | 271 |
Recalls
openFDA lists no recalls under a recalling firm named Avery Dennison Belgie Bvba.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Avery Intl. (12 510(k)s)
- Avery Dennison Corporation (1 510(k)s)
- Avery Dennison Medical , Ltd. (1 510(k)s)
- Avery Biomedical Devices, Inc. (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Avery Dennison Belgie Bvba?
FDA lists 5 510(k) clearances under the applicant name “Avery Dennison Belgie Bvba” (first 2012, latest 2021), across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Avery Dennison Belgie Bvba?
The median time from FDA receipt to decision across 510(k)s cleared under the name Avery Dennison Belgie Bvba is 157 days.
Which FDA product codes appear under Avery Dennison Belgie Bvba?
The most frequent FDA product codes under this applicant name are FRO (Dressing, Wound, Drug, 4); KKX (Drape, Surgical, Antimicrobial, 1).
Next steps
- See all 5 Avery Dennison Belgie Bvba clearances with predicates and recalls
- Run predicate analysis for product code FRO, Avery Dennison Belgie Bvba's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.