Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
ODR · Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K160366 | Electrosurgical disposable grounding pads | Top-Rank Health Care Co., Ltd. | 2016-08-19 | 192 | 0 |
| K121268 | WANDY DISPERSVIE ELECTRODE | Bio-Med USA, Inc. | 2012-12-20 | 238 | 0 |
| K082204 | SERIES SY DISPOSABLE ELECTROSURGICAL PAD | Ventlab Corp. | 2008-08-13 | 8 | 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