Avery Intl.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Avery Intl.” (first 1986, latest 1987), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 26 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KGX | Tape And Bandage, Adhesive | 6 | 6 |
| KKX | Drape, Surgical, Antimicrobial | 4 | 4 |
| FRO | Dressing, Wound, Drug | 2 | 2 |
Review panels
Most recent Avery Intl. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K870093 | MEDICAL ADHESIVE TAPE & BANDAGE USING PCCE FILM | KGX | 1987-02-05 | 27 |
| K870092 | MEDICAL ADHESIVE TAPE & BANDAGE USING HYTREL FILM | KGX | 1987-02-05 | 27 |
| K870021 | MEDICAL ADHESIVE TAPE AND ADHESIVE BANDAGE | KGX | 1987-02-05 | 34 |
| K870124 | SURGICAL DRAPES AND ACCESSORIES USING PEBAX FILM | KKX | 1987-02-04 | 23 |
| K870123 | SURGICAL DRAPES AND ACCESSORIES USING PCCE FILM | KKX | 1987-02-04 | 23 |
| K870122 | SURGICAL DRAPES AND ACCESSORIES USING HYTREL FILM | KKX | 1987-02-04 | 23 |
| K870091 | IV SECUREMENT DEVICE USING PCCE THERMO. FILM | KGX | 1987-02-04 | 26 |
| K870090 | IV SECUREMENT DEVICE USING HYTREL THERMO. FILM | KGX | 1987-02-04 | 26 |
| K870020 | IV SECUREMENT DEVICE | KGX | 1987-02-04 | 33 |
| K862438 | SURGICAL DRAPES AND DRAPE ACCESSORIES | KKX | 1986-07-16 | 20 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Avery Intl..
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 Dennison Belgie Bvba (5 510(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 Intl.?
FDA lists 12 510(k) clearances under the applicant name “Avery Intl.” (first 1986, latest 1987), across 3 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 Intl.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Avery Intl. is 26 days.
Which FDA product codes appear under Avery Intl.?
The most frequent FDA product codes under this applicant name are KGX (Tape And Bandage, Adhesive, 6); KKX (Drape, Surgical, Antimicrobial, 4); FRO (Dressing, Wound, Drug, 2).
Next steps
- See all 12 Avery Intl. clearances with predicates and recalls
- Run predicate analysis for product code KGX, Avery Intl.'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.