Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Samsung Mobile Display Co., Ltd. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
83 daysmedian FDA review time
182 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K112751 | SDX-4343CS | Samsung Mobile Display Co., Ltd. | 2011-11-23 | 63 | 0 |
| K112558 | DIGITAL FLAT PANEL X-RAY DETECTOR | Samsung Mobile Display Co., Ltd. | 2011-11-10 | 69 | 0 |
| K102321 | DIGITAL FLAT PANEL X-RAY DETECTOR MODEL SDX-4336CP | Samsung Mobile Display Co., Ltd. | 2011-02-11 | 178 | 0 |
| K102587 | LLX240AB01 | Samsung Mobile Display Co., Ltd. | 2010-12-01 | 83 | 0 |
| K090742 | DIGITAL FLAT PANEL X-RAY DETECTOR, MODEL LTX240AA01-A | Samsung Mobile Display Co., Ltd. | 2009-09-18 | 182 | 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