Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mcube Technology Co., Ltd. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
27 daysmedian FDA review time
57 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K201995 | CUBEScan BioCon-1100 | Mcube Technology Co., Ltd. | 2020-08-19 | 30 | 0 |
| K200749 | CUBEScan BioCon-900S | Mcube Technology Co., Ltd. | 2020-05-19 | 57 | 0 |
| K200548 | CUBEScan BioCon-1100 | Mcube Technology Co., Ltd. | 2020-03-27 | 24 | 0 |
| K171591 | CUBEScan™ BioCon-900 (Bladder Volume Measurement System) | Mcube Technology Co., Ltd. | 2017-06-22 | 22 | 0 |
| K111021 | CUBESCAN / BIOCON-700 | Mcube Technology Co., Ltd. | 2011-04-27 | 15 | 0 |
| K091518 | CUBESCAN BIOCON-500 DIAGNOSTIC ULTRASOUND SYSTEM | Mcube Technology Co., Ltd. | 2009-06-18 | 27 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda