Dallen Medical, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Dallen Medical, Inc.” (first 2011, latest 2017), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 110 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 | 4 | 144 |
| 2014 | 3 | 98 |
| 2015 | 2 | 95 |
| 2016 | 0 | — |
| 2017 | 1 | 172 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Dallen Medical, Inc. took a median 172 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 109 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HTN | Washer, Bolt Nut | 5 | 5 |
| JDR | Staple, Fixation, Bone | 4 | 4 |
| JDQ | Cerclage, Fixation | 2 | 2 |
Review panels
- Orthopedic (11)
Most recent Dallen Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K171473 | Compressyn Staple | JDR | 2017-11-07 | 172 |
| K150359 | Tensyn Plug | HTN | 2015-05-07 | 84 |
| K143092 | Tensyn Plug | HTN | 2015-02-11 | 106 |
| K141264 | TENSYN BAND, TENSYN FRACTURE PLATES | HTN | 2014-08-21 | 98 |
| K140358 | COMPRESSYN STAPLE | JDR | 2014-06-02 | 110 |
| K133858 | TENSYN BAND | HTN | 2014-02-28 | 71 |
| K132875 | COMPRESSYN STAPLE | JDR | 2013-12-30 | 108 |
| K131850 | TENSYN BAND | HTN | 2013-11-15 | 147 |
| K130431 | COMPRESSYN BAND | JDQ | 2013-07-25 | 154 |
| K122871 | COMPRESSYN STAPLE | JDR | 2013-02-07 | 141 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Dallen Medical, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Dallen Medical, Inc.?
FDA lists 11 510(k) clearances under the applicant name “Dallen Medical, Inc.” (first 2011, latest 2017), 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 Dallen Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Dallen Medical, Inc. is 110 days.
Which FDA product codes appear under Dallen Medical, Inc.?
The most frequent FDA product codes under this applicant name are HTN (Washer, Bolt Nut, 5); JDR (Staple, Fixation, Bone, 4); JDQ (Cerclage, Fixation, 2).
Next steps
- See all 11 Dallen Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HTN, Dallen Medical, 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.