Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Zhejiang Kangkang Medical-Devices 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) |
|---|---|---|---|---|---|
| K213535 | Sterile Safety Hypodermic Needles for Single Use | Zhejiang Kangkang Medical-Devices Co., Ltd. | 2022-05-13 | 189 | 0 |
| K210229 | Sterile Auto-Disable Syringes with/without Needle for Single | Zhejiang Kangkang Medical-Devices Co., Ltd. | 2022-02-15 | 383 | 0 |
| K210232 | Sterile Hypodermic Needles for Single Use | Zhejiang Kangkang Medical-Devices Co., Ltd. | 2021-09-23 | 238 | 0 |
| K210227 | Sterile syringe for single use with/without needle | Zhejiang Kangkang Medical-Devices Co., Ltd. | 2021-09-10 | 225 | 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