Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Chi Lin Technology Co., Ltd. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
15 daysmedian FDA review time
205 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K063269 | 5MP MEDICAL MONOCHROME REFERENCE DISPLAY, MODEL MDM2010-5NC | Chi Lin Technology Co., Ltd. | 2007-05-23 | 205 | 0 |
| K063579 | 2MP MEDICAL COLOR REFERENCE DISPLAY, MODEL MDC2130-2HC | Chi Lin Technology Co., Ltd. | 2006-12-14 | 14 | 0 |
| K063289 | 2MP MEDICAL MONOCHROME REFERENCE DISPLAY, MODEL MDM2130-2NC | Chi Lin Technology Co., Ltd. | 2006-11-16 | 15 | 0 |
| K063266 | 3MP MEDICAL MONOCHROME REFERENCE DISPLAY, MODEL MDM2130-3NC | Chi Lin Technology Co., Ltd. | 2006-11-09 | 10 | 0 |
| K061305 | MEDICAL DISPLAY, MDC1900-1LG (1LR) | Chi Lin Technology Co., Ltd. | 2006-05-25 | 15 | 0 |
| K061303 | MEDICAL DISPLAY, MODELS MDM 1900-1NG AND MDM 1900-1NR | Chi Lin Technology Co., Ltd. | 2006-05-25 | 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