Diros Technology, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Diros Technology, Inc.” (first 2002, latest 2017), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 108 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 | 1 | 200 |
| 2015 | 1 | 167 |
| 2016 | 0 | — |
| 2017 | 1 | 111 |
| 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 Diros Technology, Inc. took a median 111 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 128 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GXI | Probe, Radiofrequency Lesion | 5 | 5 |
| GXD | Generator, Lesion, Radiofrequency | 3 | 3 |
Review panels
- Neurology (8)
Most recent Diros Technology, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K170708 | OWL RF INSULATED CANNULAE | GXI | 2017-06-27 | 111 |
| K150371 | Diros OWL Sterile Single Use TridentTM R.F. Insulated Cannulae,Models DTR and DTRH | GXI | 2015-07-30 | 167 |
| K141586 | OWL CANNULAE | GXI | 2014-12-30 | 200 |
| K102566 | OWL CANNULAE | GXI | 2011-06-03 | 269 |
| K110593 | OWL RF PROBES | GXI | 2011-05-05 | 64 |
| K093185 | OWL UNIVERSAL RF SYSTEM URF-3AP (ML) | GXD | 2010-01-22 | 105 |
| K062758 | OWL URF-3AP | GXD | 2006-09-27 | 12 |
| K021869 | OWL RADIOFREQUENCY SYSTEM, MODEL URF-2AP | GXD | 2002-07-01 | 25 |
Recalls
openFDA lists no recalls under a recalling firm named Diros Technology, 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 Diros Technology, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Diros Technology, Inc.” (first 2002, latest 2017), 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 Diros Technology, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Diros Technology, Inc. is 108 days.
Which FDA product codes appear under Diros Technology, Inc.?
The most frequent FDA product codes under this applicant name are GXI (Probe, Radiofrequency Lesion, 5); GXD (Generator, Lesion, Radiofrequency, 3).
Next steps
- See all 8 Diros Technology, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GXI, Diros Technology, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.