Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Imedicom Co., Ltd. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
308 daysmedian FDA review time
347 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K182287 | MEDINAUT Plus | Imedicom Co., Ltd. | 2019-04-06 | 226 | 0 |
| K173541 | EPINAUT | Imedicom Co., Ltd. | 2018-08-24 | 282 | 0 |
| K153296 | MEDINAUT Kyphoplasty System | Imedicom Co., Ltd. | 2016-07-29 | 259 | 0 |
| K150915 | SPINAUT-P | Imedicom Co., Ltd. | 2016-03-18 | 347 | 0 |
| K151268 | SPINAUT-V, SPINAUT-S, SPINAUT-I | Imedicom Co., Ltd. | 2016-03-16 | 308 | 0 |
| K150789 | SPINAUT-E, SPINAUT-I | Imedicom Co., Ltd. | 2016-03-01 | 342 | 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