Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Suzhou Hengrui Disheng Medical Co., Ltd. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K193653 | Hydrophilic Coating Guide Wire | Suzhou Hengrui Disheng Medical Co., Ltd. | 2020-08-26 | 240 | 0 |
| K193647 | Superpipe Angiographic Catheter | Suzhou Hengrui Disheng Medical Co., Ltd. | 2020-07-29 | 212 | 0 |
| K171665 | Microcatheter and guide-wire system | Suzhou Hengrui Disheng Medical Co., Ltd. | 2018-01-11 | 220 | 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