The Deca Co.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “The Deca Co.” (first 1982, latest 1987), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 121 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 |
|---|---|---|---|
| HSB | Rod, Fixation, Intramedullary And Accessories | 3 | 3 |
| JEY | Plate, Bone | 1 | 1 |
| KTW | Appliance, Fixation, Nail/Blade/Plate Combination, Single Component | 1 | 1 |
Plus 1 more product codes.
Review panels
- Orthopedic (4)
- Dental (1)
Most recent The Deca Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K870041 | FLEXIBLE FASCICULATED BONE PLATE | JEY | 1987-07-17 | 193 |
| K870040 | INTRAMEDULLARY NAIL | HSB | 1987-03-26 | 80 |
| K863271 | FASCICULATED S ROD | — | 1986-12-24 | 121 |
| K863239 | FASCICULATED BOAT ROD | — | 1986-12-24 | 124 |
| K863215 | FASCICULATED I ROD | — | 1986-12-24 | 126 |
| K861183 | INTRAMEDULLARY ROD | — | 1986-08-11 | 133 |
| K854227 | FASCILULATED NAIL | HSB | 1986-02-04 | 109 |
| K830087 | INTRAMEDULLARY ROD | HSB | 1983-03-01 | 49 |
| K813340 | HIP PIN | KTW | 1982-01-29 | 65 |
Recalls
openFDA lists no recalls under a recalling firm named The Deca Co..
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 The Deca Co.?
FDA lists 9 510(k) clearances under the applicant name “The Deca Co.” (first 1982, latest 1987), across 4 product codes in 2 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 The Deca Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name The Deca Co. is 121 days.
Which FDA product codes appear under The Deca Co.?
The most frequent FDA product codes under this applicant name are HSB (Rod, Fixation, Intramedullary And Accessories, 3); JEY (Plate, Bone, 1); KTW (Appliance, Fixation, Nail/Blade/Plate Combination, Single Component, 1).
Next steps
- See all 9 The Deca Co. clearances with predicates and recalls
- Run predicate analysis for product code HSB, The Deca Co.'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.