Dunamis, LLC: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Dunamis, LLC” (first 2015, latest 2020), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 98 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 |
|---|---|---|
| 2015 | 2 | 150 |
| 2016 | 2 | 77 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 106 |
| 2020 | 1 | 81 |
| 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 Dunamis, LLC took a median 94 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 81 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 4 | 4 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | 2 | 2 |
Review panels
Most recent Dunamis, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K193245 | Dunamis PunchTac Suture Anchors | MBI | 2020-02-14 | 81 |
| K191319 | Dunamis Fixation Button System | MBI | 2019-08-29 | 106 |
| K160996 | Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mm | MBI | 2016-07-06 | 89 |
| K153746 | Dunamis Force DFX Tensile Tape | GAT | 2016-03-03 | 65 |
| K151220 | Dunamis Interference Screw | MBI | 2015-10-14 | 160 |
| K150327 | Dunamis Force DFX Suture, Size 5, Dunamis Force DFX Suture Size 2 | GAT | 2015-06-29 | 139 |
Recalls
openFDA lists no recalls under a recalling firm named Dunamis, LLC.
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.
- Dunamis Medical, LLC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Dunamis, LLC?
FDA lists 6 510(k) clearances under the applicant name “Dunamis, LLC” (first 2015, latest 2020), across 2 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 Dunamis, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Dunamis, LLC is 98 days.
Which FDA product codes appear under Dunamis, LLC?
The most frequent FDA product codes under this applicant name are MBI (Fastener, Fixation, Nondegradable, Soft Tissue, 4); GAT (Suture, Nonabsorbable, Synthetic, Polyethylene, 2).
Next steps
- See all 6 Dunamis, LLC clearances with predicates and recalls
- Run predicate analysis for product code MBI, Dunamis, LLC'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.