Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Jiangsu Vedkang Medical Science and Technology Co., Ltd. · Predicate Candidate Screening

7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

202 daysmedian FDA review time
254 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K232825Disposable SphincterotomeJiangsu Vedkang Medical Science and Technology Co., Ltd.2024-03-291980
K232752Stone Extraction Balloon (VDK-BAL-23-11/13/15-B,VDK-BAL-23-1Jiangsu Vedkang Medical Science and Technology Co., Ltd.2024-02-261710
K232245VedDilator ^TM (3-Stage Balloon Dilation Catheter)Jiangsu Vedkang Medical Science and Technology Co., Ltd.2024-02-152020
K230598Stone Extraction BasketsJiangsu Vedkang Medical Science and Technology Co., Ltd.2023-09-121930
K222146Disposable Endoscopic HemoclipJiangsu Vedkang Medical Science and Technology Co., Ltd.2023-03-282510
K220089Disposable Polyp SnareJiangsu Vedkang Medical Science and Technology Co., Ltd.2022-09-222540
K213914Injection NeedleJiangsu Vedkang Medical Science and Technology Co., Ltd.2022-07-292260

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