Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Hyundae Meditech Co., Ltd. · Predicate Candidate Screening
2 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242571 | Secret Line up (FC1938E80 FC1950E90 FC1960E100 FC1970E120 FC | Hyundae Meditech Co., Ltd. | 2024-09-27 | 29 | 0 |
| K240389 | Secret Line up (FCL18100C160 FCL19100E160 FCL1990E150 FCL219 | Hyundae Meditech Co., Ltd. | 2024-03-27 | 48 | 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