Van Dellen, Ltd.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Van Dellen, Ltd.” (first 1987, latest 1988), across 6 product codes in 3 review panels. Median 510(k) review time under this name: 28 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 |
|---|---|---|---|
| HMX | Cannula, Ophthalmic | 2 | 2 |
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | 1 | 1 |
| BYY | Tube, Aspirating, Flexible, Connecting | 1 | 1 |
| FPK | Tubing, Fluid Delivery | 1 | 1 |
| HNY | Cystotome | 1 | 1 |
| JOL | Catheter And Tip, Suction | 1 | 1 |
Review panels
Most recent Van Dellen, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K873465 | VAN DELLEN BACTERIA FILTER | FPK | 1988-01-20 | 145 |
| K873464 | VAN DELLEN CANNULA | JOL | 1987-11-23 | 87 |
| K873463 | VAN DELLEN ASPIRATING TUBING | BYY | 1987-11-23 | 87 |
| K873462 | VAN DELLEN ASPIRATOR | BTA | 1987-09-25 | 28 |
| K873164 | VAN DELLEN HEALON CANNULA | HMX | 1987-09-04 | 24 |
| K873163 | VAN DELLEN IRRIGATING CYSTOTOME | HNY | 1987-09-04 | 24 |
| K873162 | VAN DELLEN RETROBULBAR NEEDLE | HMX | 1987-09-04 | 24 |
Recalls
openFDA lists no recalls under a recalling firm named Van Dellen, 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 Van Dellen, Ltd.?
FDA lists 7 510(k) clearances under the applicant name “Van Dellen, Ltd.” (first 1987, latest 1988), across 6 product codes in 3 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 Van Dellen, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Van Dellen, Ltd. is 28 days.
Which FDA product codes appear under Van Dellen, Ltd.?
The most frequent FDA product codes under this applicant name are HMX (Cannula, Ophthalmic, 2); BTA (Pump, Portable, Aspiration (Manual Or Powered), 1); BYY (Tube, Aspirating, Flexible, Connecting, 1).
Next steps
- See all 7 Van Dellen, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code HMX, Van Dellen, 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.