Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Jiangsu Kangbao Medical Equipment Co., Ltd. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
183 daysmedian FDA review time
306 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K232881 | Winged Infusion Set, Safety Winged Infusion Set, Blood Colle | Jiangsu Kangbao Medical Equipment Co., Ltd. | 2023-12-22 | 95 | 0 |
| K221247 | Sterile Disposable Syringe with Safety Needle, Sterile Dispo | Jiangsu Kangbao Medical Equipment Co., Ltd. | 2022-11-01 | 183 | 0 |
| K211329 | Sterile Disposable Syringe with Saftey Needle, Sterile Dispo | Jiangsu Kangbao Medical Equipment Co., Ltd. | 2021-11-15 | 196 | 0 |
| K192681 | Safety scalp vein set, Scalp vein set, Blood collection need | Jiangsu Kangbao Medical Equipment Co., Ltd. | 2020-07-28 | 306 | 0 |
| K182649 | Enteral Feeding Syringes with Enfit Connectors | Jiangsu Kangbao Medical Equipment Co., Ltd. | 2018-11-09 | 46 | 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