Dana Products, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Dana Products, Inc.” (first 2002, latest 2014), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 175 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 | 2 | 338 |
| 2014 | 1 | 110 |
| 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 |
|---|---|---|---|
| JOJ | Indicator, Physical/Chemical Sterilization Process | 6 | 6 |
| FRC | Indicator, Biological Sterilization Process | 3 | 3 |
Review panels
- General Hospital (9)
Most recent Dana Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K133267 | DANA REUSABLE TEST PACK | FRC | 2014-02-11 | 110 |
| K130135 | DANA REUSABLE BI TEST PACK | JOJ | 2013-11-25 | 311 |
| K120592 | DANA REUSABLE BOWIE TEST PACK FOR DANA BOWIE DICK INDICATORS | JOJ | 2013-02-27 | 365 |
| K110253 | REUSABLE TEST PACK FOR DANA EMULATING INDICATORS | JOJ | 2011-04-29 | 91 |
| K103321 | DANA REUSABLE TESTPACK FOR STEAM STERILIZATION FOR 10 MINUTE EXTENDED CYCLES | FRC | 2011-02-16 | 96 |
| K100891 | DANA EMULATING INDICATOR | JOJ | 2011-01-13 | 288 |
| K102761 | DANA REUSABLE TEST PACK FOR STEAM STERILIZATION | JOJ | 2010-12-20 | 88 |
| K092944 | DANA REUSABLE TEST PACK FOR STEAM STERILIZATION | FRC | 2010-03-18 | 175 |
| K012195 | STEAM STERILIZATION INTERGRATOR | JOJ | 2002-05-07 | 298 |
Recalls
openFDA lists no recalls under a recalling firm named Dana Products, Inc..
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.
- Dana Laboratories (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Dana Products, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Dana Products, Inc.” (first 2002, latest 2014), across 2 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 Dana Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Dana Products, Inc. is 175 days.
Which FDA product codes appear under Dana Products, Inc.?
The most frequent FDA product codes under this applicant name are JOJ (Indicator, Physical/Chemical Sterilization Process, 6); FRC (Indicator, Biological Sterilization Process, 3).
Next steps
- See all 9 Dana Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JOJ, Dana Products, 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.