Adri: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Adri” (first 1987, latest 2004), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 94 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 |
|---|---|---|---|
| KMF | Bandage, Liquid | 2 | 2 |
| FRO | Dressing, Wound, Drug | 1 | 1 |
| KGN | Wound Dressing With Animal-Derived Material(S) | 1 | 1 |
| KHR | Absorber, Saliva, Paper | 1 | 1 |
| MGQ | Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic | 1 | 1 |
Review panels
Most recent Adri 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K041268 | SILVERSITE OR CALGITROL | MGQ | 2004-09-20 | 131 |
| K011618 | CALGITROL AG SILVER ALGINATE WOUND DRESSING | FRO | 2002-11-15 | 539 |
| K000054 | FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING WITH COLLAGEN | KGN | 2000-03-13 | 66 |
| K963656 | FOAM CALCIUM ALIGINATE TOPICAL WOUND DRESSING | KMF | 1996-11-12 | 61 |
| K940404 | ALGINATE FIBER TOPICAL WOUND DRESSING | KMF | 1994-05-04 | 97 |
| K870383 | ALGINATE WOOL FIBER | KHR | 1987-04-30 | 90 |
Recalls
openFDA lists no recalls under a recalling firm named Adri.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Adri?
FDA lists 6 510(k) clearances under the applicant name “Adri” (first 1987, latest 2004), across 5 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 Adri?
The median time from FDA receipt to decision across 510(k)s cleared under the name Adri is 94 days.
Which FDA product codes appear under Adri?
The most frequent FDA product codes under this applicant name are KMF (Bandage, Liquid, 2); FRO (Dressing, Wound, Drug, 1); KGN (Wound Dressing With Animal-Derived Material(S), 1).
Next steps
- See all 6 Adri clearances with predicates and recalls
- Run predicate analysis for product code KMF, Adri'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.