Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Shenzhen New Industries Biomedical Engineering Co., Ltd. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
122 daysmedian FDA review time
290 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K232587 | MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminesc | Shenzhen New Industries Biomedical Engineering Co., Ltd. | 2024-04-12 | 231 | 0 |
| K192547 | MAGLUMI 2000 HCG/ß-HCG | Shenzhen New Industries Biomedical Engineering Co., Ltd. | 2020-01-17 | 122 | 0 |
| K191499 | MAGLUMI 2000 25-OH Vitamin D | Shenzhen New Industries Biomedical Engineering Co., Ltd. | 2019-08-01 | 56 | 0 |
| K182423 | MAGLUMI 2000 FT4 | Shenzhen New Industries Biomedical Engineering Co., Ltd. | 2018-10-04 | 28 | 0 |
| K162698 | MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer | Shenzhen New Industries Biomedical Engineering Co., Ltd. | 2017-07-14 | 290 | 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