Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dmetec.Co., Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
193 daysmedian FDA review time
349 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K170104 | COMPACT S, COMPACT S (LED) | Dmetec.Co., Ltd. | 2017-12-27 | 349 | 0 |
| K121620 | ULTRASONIC SURGERY | Dmetec.Co., Ltd. | 2012-12-11 | 193 | 0 |
| K113152 | ULTRASONIC SURGERY MACHINE | Dmetec.Co., Ltd. | 2012-06-14 | 233 | 0 |
| K060171 | CLEANSE S+ ULTRASONIC SCALER | Dmetec.Co., Ltd. | 2006-03-29 | 65 | 0 |
| K051571 | SKYLIGHT LED CURING LIGHT | Dmetec.Co., Ltd. | 2005-07-19 | 35 | 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