Xoran Technologies, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Xoran Technologies, Inc.” (first 2003, latest 2022), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 90 days. Since 2017 the median was 108 days, against 121 days for all cleared 510(k)s in the same product codes. 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 | 1 | 236 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 141 |
| 2021 | 1 | 108 |
| 2022 | 1 | 90 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Xoran Technologies, Inc. took a median 108 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 121 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JAK | System, X-Ray, Tomography, Computed | 3 | 3 |
| LLZ | System, Image Processing, Radiological | 2 | 2 |
| KPR | System, X-Ray, Stationary | 1 | 1 |
| OWB | Interventional Fluoroscopic X-Ray System | 1 | 1 |
Review panels
- Radiology (7)
Most recent Xoran Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K221230 | TRON | OWB | 2022-07-28 | 90 |
| K210257 | Xoran Workstation, Model 10050 | LLZ | 2021-05-20 | 108 |
| K201825 | MiniCAT 2D | KPR | 2020-11-20 | 141 |
| K113421 | MINICAT | JAK | 2012-07-11 | 236 |
| K073306 | XORANCONNECT | LLZ | 2008-01-07 | 45 |
| K061834 | XCAT; XCAT FOR NEURO | JAK | 2006-08-07 | 39 |
| K032243 | MINICAT DENTOCAT | JAK | 2003-10-02 | 72 |
Recalls
11 product recalls in 10 recall events; 0 initiated in the last five years. Most recent: 2014-09-08.
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 Xoran Technologies, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Xoran Technologies, Inc.” (first 2003, latest 2022), across 4 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 Xoran Technologies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Xoran Technologies, Inc. is 90 days. Since 2017: 108 days, versus 121 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Xoran Technologies, Inc.?
The most frequent FDA product codes under this applicant name are JAK (System, X-Ray, Tomography, Computed, 3); LLZ (System, Image Processing, Radiological, 2); KPR (System, X-Ray, Stationary, 1).
Next steps
- See all 7 Xoran Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JAK, Xoran Technologies, 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.