Name: Predicase
Price: 199 USD

K-number	K230080
Device name	Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Blood
Applicant	Yangzhou Medline Industry, Co., Ltd.
Product code	JKA
Device class	Class II
Decision date	Jul 7, 2023
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 Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Blood

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