Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Jiangsu Caina Medical Co.,Ltd · Predicate Candidate Screening

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

178 daysmedian FDA review time
267 days90th percentile
15clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K232781Safety Sliding Blood Collection SetJiangsu Caina Medical Co.,Ltd2024-03-071780
K233190ENFit AdaptorJiangsu Caina Medical Co.,Ltd2024-01-181120
K230635Pen NeedleJiangsu Caina Medical Co.,Ltd2023-06-02870
K220184Pump Alignment SyringeJiangsu Caina Medical Co.,Ltd2022-07-211780
K211593Enteral Pump SyringeJiangsu Caina Medical Co.,Ltd2021-09-301290
K210217Needleless ConnectorJiangsu Caina Medical Co.,Ltd2021-05-171100
K200463Huber Needle Infusion Set, Safety Huber Needle Infusion SetJiangsu Caina Medical Co.,Ltd2021-04-074070
K201356Plastic LOR SyringeJiangsu Caina Medical Co.,Ltd2021-02-122670
K200027Blood Collection Needle with/without Holder, Safety Blood CoJiangsu Caina Medical Co.,Ltd2020-09-092470
K193022Retractable Safety Insulin SyringeJiangsu Caina Medical Co.,Ltd2020-07-202640
K193526Syringe with safety needle, Safety needleJiangsu Caina Medical Co.,Ltd2020-07-172110
K191490Retractable Safety Syringe, Retractable Safety Insulin SyrinJiangsu Caina Medical Co.,Ltd2019-10-031200
K190502ENFit Oral / Enteral SyringeJiangsu Caina Medical Co.,Ltd2019-08-061584
K181374NRFit SyringeJiangsu Caina Medical Co.,Ltd2018-12-142040
K172938Disposable Sterile NeedleJiangsu Caina Medical Co.,Ltd2018-06-142610

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