Mcube Technology Co., Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Mcube Technology Co., Ltd.” (first 2009, latest 2020), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 26 days. Since 2017 the median was 27 days, against 126 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 22 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 3 | 30 |
| 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 Mcube Technology Co., Ltd. took a median 27 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 126 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 5 | 5 |
| ITX | Transducer, Ultrasonic, Diagnostic | 1 | 1 |
Review panels
- Radiology (6)
Most recent Mcube Technology Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K201995 | CUBEScan BioCon-1100 | IYO | 2020-08-19 | 30 |
| K200749 | CUBEScan BioCon-900S | IYO | 2020-05-19 | 57 |
| K200548 | CUBEScan BioCon-1100 | IYO | 2020-03-27 | 24 |
| K171591 | CUBEScan BioCon-900 (Bladder Volume Measurement System) | IYO | 2017-06-22 | 22 |
| K111021 | CUBESCAN / BIOCON-700 | ITX | 2011-04-27 | 15 |
| K091518 | CUBESCAN BIOCON-500 DIAGNOSTIC ULTRASOUND SYSTEM | IYO | 2009-06-18 | 27 |
Recalls
openFDA lists no recalls under a recalling firm named Mcube Technology Co., Ltd..
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 Mcube Technology Co., Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Mcube Technology Co., Ltd.” (first 2009, latest 2020), 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 Mcube Technology Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Mcube Technology Co., Ltd. is 26 days. Since 2017: 27 days, versus 126 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Mcube Technology Co., Ltd.?
The most frequent FDA product codes under this applicant name are IYO (System, Imaging, Pulsed Echo, Ultrasonic, 5); ITX (Transducer, Ultrasonic, Diagnostic, 1).
Next steps
- See all 6 Mcube Technology Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code IYO, Mcube Technology Co., Ltd.'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.