Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Shenzhen Biocare Bio-Medical Equipment Co., Ltd. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
148 daysmedian FDA review time
392 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K160092 | Digital Electrocardiograph | Shenzhen Biocare Bio-Medical Equipment Co., Ltd. | 2016-02-12 | 28 | 0 |
| K152384 | Digital Electrocardiograph | Shenzhen Biocare Bio-Medical Equipment Co., Ltd. | 2015-12-18 | 116 | 0 |
| K141946 | DIGITAL ELECTROCARDIOGRAPH | Shenzhen Biocare Bio-Medical Equipment Co., Ltd. | 2015-02-13 | 211 | 0 |
| K133985 | DIGITAL ELECTROCARDIOGRAPH | Shenzhen Biocare Bio-Medical Equipment Co., Ltd. | 2015-01-22 | 392 | 0 |
| K132758 | DIGITAL ELECTROCARDIOGRAPH | Shenzhen Biocare Bio-Medical Equipment Co., Ltd. | 2014-01-30 | 148 | 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