Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sm Eng Co., Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
242 daysmedian FDA review time
378 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K200392 | REXSIN | Sm Eng Co., Ltd. | 2020-07-07 | 140 | 0 |
| K173747 | REXLENE | Sm Eng Co., Ltd. | 2018-12-21 | 378 | 0 |
| K173779 | REXMONO, PDREX | Sm Eng Co., Ltd. | 2018-03-12 | 90 | 0 |
| K161633 | REXLON, REXSIL | Sm Eng Co., Ltd. | 2017-03-02 | 262 | 0 |
| K161629 | CRYLREX | Sm Eng Co., Ltd. | 2017-02-10 | 242 | 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