Duckworth & Kent, Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Duckworth & Kent, Ltd.” (first 2003, latest 2008), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 133 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 |
|---|---|---|---|
| MSS | Folders And Injectors, Intraocular Lens (Iol) | 3 | 3 |
| KYB | Lens, Guide, Intraocular | 2 | 2 |
| NCE | Injector, Capsular Tension Ring | 1 | 1 |
Review panels
- Ophthalmic (6)
Most recent Duckworth & Kent, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K081382 | DUCKWORTH & KENT, LTD., IMPLANTATION SYSTEM, MODEL DK7786 | KYB | 2008-10-23 | 160 |
| K072985 | DUCKWORTH & KENT LTD INJECTOR, MODEL: DK7797-2 | KYB | 2008-06-20 | 241 |
| K060995 | DUCKWORTH & KENT LTD LENS DELIVERY SYSTEM, MODEL DK7788 | MSS | 2006-05-22 | 41 |
| K053176 | DUCKWORTH & KENT LTD CARTRIDGE LENS DELIVERY SYSTEM, MODEL DK7797 | MSS | 2006-01-30 | 77 |
| K042478 | CAPSULE TENSION RING INSERTER, MODEL 7-810 | NCE | 2004-12-28 | 106 |
| K024072 | DUCKWORTH & KENT LTD LENS DELIVERY SYSTEM | MSS | 2003-10-06 | 300 |
Recalls
openFDA lists no recalls under a recalling firm named Duckworth & Kent, Ltd..
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 Duckworth & Kent, Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Duckworth & Kent, Ltd.” (first 2003, latest 2008), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Duckworth & Kent, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Duckworth & Kent, Ltd. is 133 days.
Which FDA product codes appear under Duckworth & Kent, Ltd.?
The most frequent FDA product codes under this applicant name are MSS (Folders And Injectors, Intraocular Lens (Iol), 3); KYB (Lens, Guide, Intraocular, 2); NCE (Injector, Capsular Tension Ring, 1).
Next steps
- See all 6 Duckworth & Kent, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code MSS, Duckworth & Kent, Ltd.'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.