Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Jiangsu Shenli Medical Production 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) |
|---|---|---|---|---|---|
| K200557 | Enteral Feeding Syringes with ENfit connector (Model: 10 ml; | Jiangsu Shenli Medical Production Co., Ltd. | 2020-09-28 | 209 | 0 |
| K180259 | Sterile Hypodermic Needle for Single Use | Jiangsu Shenli Medical Production Co., Ltd. | 2018-05-18 | 108 | 0 |
| K163093 | Safety Blood Collection Set | Jiangsu Shenli Medical Production Co., Ltd. | 2017-03-14 | 130 | 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