Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Zhejiang Kindly Medical Devices Co., Ltd. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
226 daysmedian FDA review time
380 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K223334 | Sterile Hypodermic Needles for Single Use | Zhejiang Kindly Medical Devices Co., Ltd. | 2022-12-16 | 45 | 0 |
| K213183 | Safety Insulin Pen Needles | Zhejiang Kindly Medical Devices Co., Ltd. | 2022-10-14 | 380 | 0 |
| K181069 | Disposable Insulin Pen Needle | Zhejiang Kindly Medical Devices Co., Ltd. | 2018-08-28 | 127 | 0 |
| K172763 | Blood Collecting Needle, Safety Blood Collecting Needle, Blo | Zhejiang Kindly Medical Devices Co., Ltd. | 2018-06-04 | 264 | 0 |
| K171518 | Epidural Anesthesia Needles, Spinal Anesthesia Needles, Comb | Zhejiang Kindly Medical Devices Co., Ltd. | 2018-01-05 | 226 | 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