Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Shandong Weigao Group Medical Polymer Co., Ltd. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
178 daysmedian FDA review time
616 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K212207 | Sterile Hypodermic Syringe for Single Use | Shandong Weigao Group Medical Polymer Co., Ltd. | 2023-03-23 | 616 | 0 |
| K212920 | Sterile Safety Syringe with Needle for Single Use, Sterile S | Shandong Weigao Group Medical Polymer Co., Ltd. | 2022-03-11 | 178 | 0 |
| K102741 | ENTERAL FEEDING BAG AND SETS | Shandong Weigao Group Medical Polymer Co., Ltd. | 2011-11-08 | 412 | 0 |
| K102328 | BLUNT FILL NEEDLE AND BLUNT PLASTIC CANNULA | Shandong Weigao Group Medical Polymer Co., Ltd. | 2011-05-13 | 269 | 0 |
| K081241 | WEIGAO EMPTY CARTRIDGE SYRINGE | Shandong Weigao Group Medical Polymer Co., Ltd. | 2008-09-08 | 130 | 0 |
| K072739 | JIERUI SYRINGES AND NEEDLES | Shandong Weigao Group Medical Polymer Co., Ltd. | 2008-03-21 | 176 | 0 |
| K073127 | BLOOD COLLECTION NEEDLE, MODEL 20G 21G 22G | Shandong Weigao Group Medical Polymer Co., Ltd. | 2007-12-20 | 44 | 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