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FDA 510(k)

Kurin Blood Culture Collection Set with Kurin Lock Technology, Push-Button Needle (Product models M-21221, M-21223, D-21221, D-21223, T-21221, T-21223)

K-Number: K191832 · 2020-02-04

ApplicantKurin, Inc.
Decision Date2020-02-04
Product CodeJKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Kurin Blood Culture Collection Set with Kurin Lock Technology, Push-Button Needle (Product models M-21221, M-21223, D-21221, D-21223, T-21221, T-21223) is a medical device manufactured by Kurin, Inc.. It received FDA 510(k) clearance on 2020-02-04 under approval number K191832. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Kurin Blood Culture Collection Set with Kurin Lock Technology, Push-Button Needle (Product models M-21221, M-21223, D-21221, D-21223, T-21221, T-21223)?

Kurin Blood Culture Collection Set with Kurin Lock Technology, Push-Button Needle (Product models M-21221, M-21223, D-21221, D-21223, T-21221, T-21223) is a medical device that received FDA 510(k) clearance on 2020-02-04. It is manufactured by Kurin, Inc.. The 510(k) number is K191832.

When was Kurin Blood Culture Collection Set with Kurin Lock Technology, Push-Button Needle (Product models M-21221, M-21223, D-21221, D-21223, T-21221, T-21223) approved by the FDA?

Kurin Blood Culture Collection Set with Kurin Lock Technology, Push-Button Needle (Product models M-21221, M-21223, D-21221, D-21223, T-21221, T-21223) received FDA 510(k) clearance on 2020-02-04, under approval number K191832.

What company makes Kurin Blood Culture Collection Set with Kurin Lock Technology, Push-Button Needle (Product models M-21221, M-21223, D-21221, D-21223, T-21221, T-21223)?

Kurin Blood Culture Collection Set with Kurin Lock Technology, Push-Button Needle (Product models M-21221, M-21223, D-21221, D-21223, T-21221, T-21223) is manufactured by Kurin, Inc..

What is the FDA product code for Kurin Blood Culture Collection Set with Kurin Lock Technology, Push-Button Needle (Product models M-21221, M-21223, D-21221, D-21223, T-21221, T-21223)?

The FDA product code for Kurin Blood Culture Collection Set with Kurin Lock Technology, Push-Button Needle (Product models M-21221, M-21223, D-21221, D-21223, T-21221, T-21223) is JKA.

Related Clinical Trials

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Related PubMed Literature

PMID: 41336744 From laboratory to pre-market prototyping: lessons learned from a noninvasive blood glucose level measurement device. Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference (2025) PMID: 41328405 Paradigm Shift in Global Governance of Medical Brain-Computer Interface: Addressing Practical Challenges Through Institutional Innovation. Risk management and healthcare policy (2025) PMID: 40972375 AI-based EEG analysis: new technology and the path to clinical adoption. Clinical neurophysiology : official journal of the International Federation of Clinical Neurophysiology (2025) PMID: 40424619 Digital Therapeutics in China: Comprehensive Review. Journal of medical Internet research (2025)

Other Devices by Kurin, Inc.

K181895Kurin PIV Blood Collection Set with High Pressure K220677Kurin Blood Culture Collection Set with Kurin Lock Technology

Related Devices (Code: JKA)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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