Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sejong Medical Co., Ltd. · Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
105 daysmedian FDA review time
568 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253165 | LAP-iX2N | Sejong Medical Co., Ltd. | 2026-06-09 | 256 | 0 |
| K252985 | Laport | Sejong Medical Co., Ltd. | 2026-05-19 | 243 | 0 |
| K200639 | LAP-iX | Sejong Medical Co., Ltd. | 2021-09-29 | 568 | 0 |
| K200638 | LAP-iX Suction Irrigation | Sejong Medical Co., Ltd. | 2020-04-03 | 24 | 0 |
| K173108 | Smoklean | Sejong Medical Co., Ltd. | 2018-05-18 | 231 | 0 |
| K173111 | LAP-iX Suction Irrigation | Sejong Medical Co., Ltd. | 2017-11-28 | 60 | 0 |
| K173112 | LAP-iX | Sejong Medical Co., Ltd. | 2017-11-21 | 53 | 0 |
| K171726 | LapBag | Sejong Medical Co., Ltd. | 2017-09-25 | 105 | 0 |
| K171741 | Laport | Sejong Medical Co., Ltd. | 2017-08-29 | 78 | 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