Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Top-Rank Health Care Co., Ltd. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K232020 | Iontophoresis Electrodes | Top-Rank Health Care Co., Ltd. | 2023-10-16 | 101 | 0 |
| K222770 | Conductive Gel | Top-Rank Health Care Co., Ltd. | 2022-12-13 | 90 | 0 |
| K210223 | Transcutaneous Electrical Nerve Stimulator | Top-Rank Health Care Co., Ltd. | 2021-12-15 | 321 | 0 |
| K160366 | Electrosurgical disposable grounding pads | Top-Rank Health Care Co., Ltd. | 2016-08-19 | 192 | 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