Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Micro-Nx Co., Ltd. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
329 daysmedian FDA review time
779 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K231562 | ELEC ENGINE (Model: ISE-170L) | Micro-Nx Co., Ltd. | 2025-07-18 | 779 | 0 |
| K232810 | Dental Handpiece, Wireless Endodontic Handpiece, endoit | Micro-Nx Co., Ltd. | 2023-11-09 | 58 | 0 |
| K220577 | Dental Handpiece, Model CA160, CA160L, and CA500L | Micro-Nx Co., Ltd. | 2022-07-29 | 151 | 0 |
| K201191 | ELEC-LED | Micro-Nx Co., Ltd. | 2022-02-07 | 644 | 0 |
| K201192 | Impla-NX (Model: ISE-270M) | Micro-Nx Co., Ltd. | 2021-05-21 | 382 | 0 |
| K192809 | Dental Handpiece | Micro-Nx Co., Ltd. | 2020-08-25 | 329 | 0 |
| K161500 | MEG-TORQ | Micro-Nx Co., Ltd. | 2017-02-22 | 266 | 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