Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Apoza Enterprise Co., Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
32 daysmedian FDA review time
211 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K070373 | APOZA LED CURING LIGHT, MODEL E-MORLIT, D-2000, TOP 3W, TOP | Apoza Enterprise Co., Ltd. | 2007-03-02 | 22 | 0 |
| K041303 | LED TURBO-PEN | Apoza Enterprise Co., Ltd. | 2004-06-18 | 32 | 0 |
| K033198 | APOZA ULTRASONIC SCALER AND EDODONTICS UNIT, SELECTOR U2 | Apoza Enterprise Co., Ltd. | 2004-04-30 | 211 | 0 |
| K040618 | LED TURBO | Apoza Enterprise Co., Ltd. | 2004-03-25 | 16 | 0 |
| K033201 | LA500 BLUE LIGHT | Apoza Enterprise Co., Ltd. | 2003-12-02 | 61 | 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