Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Alpinion Medical Systems Co., Ltd. · Predicate Candidate Screening
26 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
100 daysmedian FDA review time
139 days90th percentile
26clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K223564 | X-CUBE 50, X-CUBE 60 | Alpinion Medical Systems Co., Ltd. | 2023-04-17 | 139 | 0 |
| K221093 | X-CUBE 70, X-CUBE 90 | Alpinion Medical Systems Co., Ltd. | 2022-10-14 | 184 | 0 |
| K220857 | X-CUBE 50, X-CUBE 60 | Alpinion Medical Systems Co., Ltd. | 2022-10-13 | 204 | 0 |
| K213523 | X-CUBE i8, X-CUBE i9 | Alpinion Medical Systems Co., Ltd. | 2022-01-28 | 86 | 0 |
| K211300 | X-CUBE 90 | Alpinion Medical Systems Co., Ltd. | 2021-08-09 | 103 | 0 |
| K211299 | X-CUBE 70 | Alpinion Medical Systems Co., Ltd. | 2021-08-09 | 103 | 0 |
| K200450 | X-Cube 70 | Alpinion Medical Systems Co., Ltd. | 2020-07-10 | 137 | 0 |
| K200449 | X-Cube 90 | Alpinion Medical Systems Co., Ltd. | 2020-07-10 | 137 | 0 |
| K182594 | E-CUBE i7 | Alpinion Medical Systems Co., Ltd. | 2019-01-24 | 126 | 0 |
| K182845 | minisono | Alpinion Medical Systems Co., Ltd. | 2018-12-27 | 79 | 0 |
| K181617 | E-CUBE 8 | Alpinion Medical Systems Co., Ltd. | 2018-10-11 | 114 | 0 |
| K181277 | E-CUBE 12 | Alpinion Medical Systems Co., Ltd. | 2018-09-28 | 137 | 0 |
| K172732 | E-CUBE 8 | Alpinion Medical Systems Co., Ltd. | 2017-12-14 | 94 | 0 |
| K161439 | E-CUBE 11 | Alpinion Medical Systems Co., Ltd. | 2016-09-21 | 120 | 0 |
| K153424 | E-CUBE i7 | Alpinion Medical Systems Co., Ltd. | 2016-02-26 | 93 | 0 |
| K150773 | E-CUBE 15 Diagnostic Ultrasound System | Alpinion Medical Systems Co., Ltd. | 2015-07-23 | 121 | 0 |
| K142884 | E-CUBE 12 | Alpinion Medical Systems Co., Ltd. | 2014-10-28 | 26 | 0 |
| K142733 | E-CUBE 5 | Alpinion Medical Systems Co., Ltd. | 2014-10-28 | 35 | 0 |
| K132687 | E-CUBE 7 | Alpinion Medical Systems Co., Ltd. | 2013-11-27 | 91 | 0 |
| K123610 | E-CUBE 15 | Alpinion Medical Systems Co., Ltd. | 2013-02-01 | 72 | 0 |
| K123611 | E-CUBE 7 | Alpinion Medical Systems Co., Ltd. | 2012-12-21 | 30 | 0 |
| K121729 | E-CUBE 7 | Alpinion Medical Systems Co., Ltd. | 2012-09-20 | 100 | 0 |
| K121888 | E-CUBE 15 | Alpinion Medical Systems Co., Ltd. | 2012-07-26 | 28 | 0 |
| K121937 | E-CUBE INNO | Alpinion Medical Systems Co., Ltd. | 2012-07-26 | 24 | 0 |
| K120060 | E-CUBE 9 | Alpinion Medical Systems Co., Ltd. | 2012-03-16 | 67 | 0 |
| K111864 | E-CUBE 9 | Alpinion Medical Systems Co., Ltd. | 2011-07-15 | 15 | 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