Name: Predicase
Price: 199 USD

K-number	K200027
Device name	Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without Holder, Luer Access Device-holder with Preattached Multiple Sample Adapter
Applicant	Jiangsu Caina Medical Co.,Ltd
Product code	JKA
Device class	Class II
Decision date	Sep 9, 2020
Decision	Substantially Equivalent
Regulation	862.1675

AI Summary

AI extraction for this record is queued and will appear within 24 hours. View full FDA record →

Source

View the full FDA submission: accessdata.fda.gov

Researching this as a predicate?

Want a transparent AI-ranking score, AI-discovered related predicates, ongoing safety and warning-letter monitoring, full predicate chain lineage, and a drafted SE rationale — all saved to your own project? That's what an account adds.

Start free trial →

Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without Holder, Luer Access Device-holder with Preattached Multiple Sample Adapter

Everything you need for a 510(k) submission. Nothing you don't.