Dms Products, Inc.: FDA clearances and approvals
Dms Products, Inc. has 6 FDA 510(k) clearances (first 1986, latest 1989), across 5 product codes in 1 review panel. Median 510(k) review time: 100 days.
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 |
|---|---|---|---|
| JSS | Kit, Identification, Enterobacteriaceae | 2 | 2 |
| JST | Kit, Fastidious Organisms | 1 | 1 |
| JTO | Discs, Strips And Reagents, Microorganism Differentiation | 1 | 1 |
| JXA | Kit, Screening, Urine | 1 | 1 |
| LQL | Gram Positive Identification Panel | 1 | 1 |
Review panels
- Microbiology (6)
Most recent Dms Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K891004 | RAPIDEC STAPH | LQL | 1989-11-09 | 254 |
| K894805 | RAPIDEC UR | JXA | 1989-09-26 | 60 |
| K890626 | RAPIDEC COLI | JSS | 1989-06-02 | 115 |
| K890625 | JAMES REAGENT | JTO | 1989-02-17 | 10 |
| K854733 | API 20 EC (ENTEROBACTERIACEAE)(IDENTIFICATION KIT) | JSS | 1986-03-06 | 101 |
| K854732 | API 50 CHB (CULTURE MEDIA) | JST | 1986-03-04 | 99 |
Recalls
openFDA lists no recalls under a recalling firm named Dms Products, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Dms Products, Inc. have?
Dms Products, Inc. has 6 FDA 510(k) clearances (first 1986, latest 1989), across 5 product codes in 1 review panel.
How long does FDA take to clear Dms Products, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Dms Products, Inc.'s cleared 510(k)s is 100 days.
What devices does Dms Products, Inc. make?
Its most frequent FDA product codes are JSS (Kit, Identification, Enterobacteriaceae, 2); JST (Kit, Fastidious Organisms, 1); JTO (Discs, Strips And Reagents, Microorganism Differentiation, 1).
Has Dms Products, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Dms Products, Inc. Related entities may recall under other names.
Next steps
- See all 6 Dms Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JSS, Dms Products, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.