Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Easy Med Instrument 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) |
|---|---|---|---|---|---|
| K153045 | SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral | Easy Med Instrument Co., Ltd. | 2016-05-13 | 207 | 0 |
| K143430 | SmartTENS | Easy Med Instrument Co., Ltd. | 2015-05-29 | 179 | 0 |
| K050921 | EASYSTIM NMS-28 | Easy Med Instrument Co., Ltd. | 2005-12-12 | 243 | 0 |
| K040253 | EASY MED TN-28 C | Easy Med Instrument Co., Ltd. | 2004-04-08 | 64 | 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