Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Monitex Industrial Co., Ltd. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
207 daysmedian FDA review time
611 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K161855 | LED Curing Light | Monitex Industrial Co., Ltd. | 2017-11-27 | 509 | 0 |
| K152192 | LED Curing Light | Monitex Industrial Co., Ltd. | 2017-04-07 | 611 | 0 |
| K153078 | LED Curing Light GT-2000 | Monitex Industrial Co., Ltd. | 2016-06-28 | 249 | 0 |
| K150205 | LED Curing Light | Monitex Industrial Co., Ltd. | 2015-08-24 | 207 | 0 |
| K133040 | LED CURING LIGHT | Monitex Industrial Co., Ltd. | 2014-10-07 | 377 | 0 |
| K091887 | LED CURING LIGHT, MODEL GT-1500 | Monitex Industrial Co., Ltd. | 2009-09-18 | 86 | 0 |
| K080035 | LED CURING LIGHT | Monitex Industrial Co., Ltd. | 2008-03-03 | 56 | 0 |
| K060646 | BLUE LUXCER CURING LIGHT, MODELS M-830, M-835 AND M-855 | Monitex Industrial Co., Ltd. | 2006-04-21 | 42 | 0 |
| K051203 | BLUELEX | Monitex Industrial Co., Ltd. | 2005-05-25 | 14 | 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