Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Shandong Zhushi Pharmaceutical Group Co., Ltd. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
167 daysmedian FDA review time
414 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K232475 | Disposable infusion set with needle | Shandong Zhushi Pharmaceutical Group Co., Ltd. | 2024-05-10 | 268 | 0 |
| K212033 | Disposable Sterile Syringe, with/without needle;luer/luer-lo | Shandong Zhushi Pharmaceutical Group Co., Ltd. | 2022-08-17 | 414 | 0 |
| K210510 | Disposable Surgical Gown | Shandong Zhushi Pharmaceutical Group Co., Ltd. | 2021-08-12 | 171 | 0 |
| K210643 | Disposable Surgical Face Mask | Shandong Zhushi Pharmaceutical Group Co., Ltd. | 2021-08-04 | 154 | 0 |
| K210409 | Disposable Surgical Face Mask | Shandong Zhushi Pharmaceutical Group Co., Ltd. | 2021-07-28 | 167 | 0 |
| K203454 | Infrared Thermometer | Shandong Zhushi Pharmaceutical Group Co., Ltd. | 2021-04-29 | 157 | 0 |
| K203436 | Disposable Nitrile Examination Gloves | Shandong Zhushi Pharmaceutical Group Co., Ltd. | 2021-04-28 | 156 | 0 |
| K203439 | Disposable Vinyl Examination Gloves | Shandong Zhushi Pharmaceutical Group Co., Ltd. | 2021-02-26 | 95 | 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