Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Shenzhen Changke Connect Electronics Co., Ltd. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
136 daysmedian FDA review time
211 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K213884 | Disposable EEG cable | Shenzhen Changke Connect Electronics Co., Ltd. | 2022-05-06 | 144 | 0 |
| K193625 | Disposable Temperature Probe | Shenzhen Changke Connect Electronics Co., Ltd. | 2020-07-24 | 211 | 0 |
| K200026 | Disposable ECG Cable | Shenzhen Changke Connect Electronics Co., Ltd. | 2020-05-12 | 127 | 0 |
| K193629 | Disposable NIBP Cuff | Shenzhen Changke Connect Electronics Co., Ltd. | 2020-03-25 | 90 | 0 |
| K200069 | Disposable SpO2 Sensor | Shenzhen Changke Connect Electronics Co., Ltd. | 2020-03-13 | 60 | 0 |
| K191428 | ECG Cable | Shenzhen Changke Connect Electronics Co., Ltd. | 2019-11-27 | 182 | 0 |
| K191420 | Reusable SpO2 Sensor | Shenzhen Changke Connect Electronics Co., Ltd. | 2019-10-11 | 136 | 0 |
| K191253 | Reusable NIBP Cuff | Shenzhen Changke Connect Electronics Co., Ltd. | 2019-09-17 | 131 | 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