Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Shenzhen Biocare Electronics Co., Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
77 daysmedian FDA review time
238 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K123816 | DIGITAL ELECTROCARDIOGRAPHS | Shenzhen Biocare Electronics Co., Ltd. | 2013-02-27 | 77 | 0 |
| K122712 | DIGITAL ELECTROCARDIOGRAPH | Shenzhen Biocare Electronics Co., Ltd. | 2012-10-25 | 51 | 0 |
| K112431 | DIGITAL ELECTROCARDIOGRAPH | Shenzhen Biocare Electronics Co., Ltd. | 2011-09-22 | 30 | 0 |
| K101876 | DIGITAL ELECTROCARDIOGRAPH, MODELS ECG-1210, ECG-1230, ECG-3 | Shenzhen Biocare Electronics Co., Ltd. | 2011-03-01 | 238 | 0 |
| K100626 | DOPPLER FETAL HEART RATE DETECTOR, MODEL FM-200 | Shenzhen Biocare Electronics Co., Ltd. | 2010-05-21 | 77 | 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