Atlas FDA

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-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K213884Disposable EEG cableShenzhen Changke Connect Electronics Co., Ltd.2022-05-061440
K193625Disposable Temperature ProbeShenzhen Changke Connect Electronics Co., Ltd.2020-07-242110
K200026Disposable ECG CableShenzhen Changke Connect Electronics Co., Ltd.2020-05-121270
K193629Disposable NIBP CuffShenzhen Changke Connect Electronics Co., Ltd.2020-03-25900
K200069Disposable SpO2 SensorShenzhen Changke Connect Electronics Co., Ltd.2020-03-13600
K191428ECG CableShenzhen Changke Connect Electronics Co., Ltd.2019-11-271820
K191420Reusable SpO2 SensorShenzhen Changke Connect Electronics Co., Ltd.2019-10-111360
K191253Reusable NIBP CuffShenzhen Changke Connect Electronics Co., Ltd.2019-09-171310

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