Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Nec Display Solutions , Ltd. · Predicate Candidate Screening
15 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
29 daysmedian FDA review time
76 days90th percentile
15clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K161057 | Diagnostic Imaging Color LCD Monitor | Nec Display Solutions , Ltd. | 2016-05-13 | 29 | 0 |
| K150145 | MD322C8 31.5 Diagnostic Imaging LCD Monitor | Nec Display Solutions , Ltd. | 2015-02-06 | 15 | 0 |
| K142951 | MD210C3 21.3 Diagnostic Imaging LCD Monitor | Nec Display Solutions , Ltd. | 2014-12-10 | 61 | 0 |
| K133708 | MD302C4 29.8 DIAGNOSTIC IMAGING LCD MONITOR | Nec Display Solutions , Ltd. | 2014-02-14 | 72 | 0 |
| K130772 | MD211C2 21.3 DIAGNOSTIC IMAGING LCD MONITOR | Nec Display Solutions , Ltd. | 2013-04-18 | 29 | 0 |
| K130770 | MD211C3 21.3 DIAGNOSTIC IMAGING LCD MONITOR | Nec Display Solutions , Ltd. | 2013-04-18 | 29 | 0 |
| K111237 | MD301C4 29.8 DIAGNOSTIC IMAGING LCD MONITOR, L309TY | Nec Display Solutions , Ltd. | 2011-06-15 | 44 | 0 |
| K090218 | MD213MC 21.3 DIAGNOSTIC IMAGING LCD MONITOR MODEL, L218TJ | Nec Display Solutions , Ltd. | 2009-04-15 | 76 | 0 |
| K090215 | MD213MG 21.3 DIAGNOSTIC IMAGING LCD MONITOR - L218TL | Nec Display Solutions , Ltd. | 2009-04-15 | 76 | 0 |
| K083916 | LCD3090WQXI OR MD304MC 29.8 INCH DIAGNOSTIC IMAGING LCD MONI | Nec Display Solutions , Ltd. | 2009-01-14 | 15 | 0 |
| K083907 | MD212MC 21.3 DIAGNOSTIC IMAGING LCD MONITOR-L217TG | Nec Display Solutions , Ltd. | 2009-01-13 | 14 | 0 |
| K083332 | MD21M 21.3 DIAGNOSTIC IMAGING LCD MONITOR, MODEL L218TK | Nec Display Solutions , Ltd. | 2009-01-09 | 58 | 0 |
| K082493 | MEDICAL DISPLAY, MD205MG-1 | Nec Display Solutions , Ltd. | 2008-10-23 | 55 | 0 |
| K073448 | MEDICAL DISPLAY, MD205MG | Nec Display Solutions , Ltd. | 2007-12-20 | 10 | 0 |
| K061947 | 21.3 INCH MONOCHROME LCD MONITOR | Nec Display Solutions , Ltd. | 2006-07-25 | 15 | 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