Atlas FDA

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-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K160092Digital ElectrocardiographShenzhen Biocare Bio-Medical Equipment Co., Ltd.2016-02-12280
K152384Digital ElectrocardiographShenzhen Biocare Bio-Medical Equipment Co., Ltd.2015-12-181160
K141946DIGITAL ELECTROCARDIOGRAPHShenzhen Biocare Bio-Medical Equipment Co., Ltd.2015-02-132110
K133985DIGITAL ELECTROCARDIOGRAPHShenzhen Biocare Bio-Medical Equipment Co., Ltd.2015-01-223920
K132758DIGITAL ELECTROCARDIOGRAPHShenzhen Biocare Bio-Medical Equipment Co., Ltd.2014-01-301480

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