Varian, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Varian, Inc.” (first 2004, latest 2006), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 46 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Siemens Healthineers, based on public ownership records.
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 |
|---|---|---|---|
| DKZ | Enzyme Immunoassay, Amphetamine | 3 | 3 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 1 | 1 |
| DJC | Thin Layer Chromatography, Methamphetamine | 1 | 1 |
Review panels
Most recent Varian, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K060896 | MODIFICATION TO ONTRAK TESTCUP II AND ONSITE CUPKIT | DJC | 2006-06-09 | 67 |
| K051235 | ON TRAK TESTCARD | DKZ | 2005-06-08 | 26 |
| K050321 | ONTRAK TESTCARD 9 | DIO | 2005-04-18 | 68 |
| K033902 | ONTRAK TESTCUP II AND ONSITE CUPKIT | DKZ | 2004-01-20 | 34 |
| K033659 | VARIAN, INC. ONTRAK TESTCUP AND ONTRAK TESTSTIK | DKZ | 2004-01-06 | 46 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2003-07-18.
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.
- Varian Medical Systems, Inc. (206 510(k)s)
- Varian Assoc., Inc. (86 510(k)s)
- Varian Canada, Inc. (7 510(k)s)
- Varian Medical Systems, Oncology Systems (4 510(k)s)
- Varian Medical Systems, X-Ray Products-Infimed (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Varian, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Varian, Inc.” (first 2004, latest 2006), 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 Varian, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Varian, Inc. is 46 days.
Which FDA product codes appear under Varian, Inc.?
The most frequent FDA product codes under this applicant name are DKZ (Enzyme Immunoassay, Amphetamine, 3); DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites, 1); DJC (Thin Layer Chromatography, Methamphetamine, 1).
Next steps
- See all 5 Varian, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DKZ, Varian, Inc.'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.