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FDA 510(k)

Safety Blood Collection Needle (Without Needle Holder)

K-Number: K222141 · 2022-10-21

ApplicantAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.
Decision Date2022-10-21
Product CodeJKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Safety Blood Collection Needle (Without Needle Holder) is a medical device manufactured by Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.. It received FDA 510(k) clearance on 2022-10-21 under approval number K222141. 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 Safety Blood Collection Needle (Without Needle Holder)?

Safety Blood Collection Needle (Without Needle Holder) is a medical device that received FDA 510(k) clearance on 2022-10-21. It is manufactured by Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.. The 510(k) number is K222141.

When was Safety Blood Collection Needle (Without Needle Holder) approved by the FDA?

Safety Blood Collection Needle (Without Needle Holder) received FDA 510(k) clearance on 2022-10-21, under approval number K222141.

What company makes Safety Blood Collection Needle (Without Needle Holder)?

Safety Blood Collection Needle (Without Needle Holder) is manufactured by Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd..

What is the FDA product code for Safety Blood Collection Needle (Without Needle Holder)?

The FDA product code for Safety Blood Collection Needle (Without Needle Holder) is JKA.

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Related PubMed Literature

PMID: 40388896 Accuracy and Safety of a Continuous Noninvasive Blood Pressure Monitor in Neonates. Neonatology (2025) PMID: 37966871 Collection and Analysis of Adherence Information for Software as a Medical Device Clinical Trials: Systematic Review. JMIR mHealth and uHealth (2023) PMID: 34056520 Remote Cardiac Safety Monitoring through the Lens of the FDA Biomarker Qualification Evidentiary Criteria Framework: A Case Study Analysis. Digital biomarkers (2021) PMID: 32309074 Postmarket Modifications of High-risk Plastic Surgery Devices. Plastic and reconstructive surgery. Global open (2020)

Other Devices by Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.

K190183Hypodermic Safety Needle, Hypodermic Safety Needle with Syringe K211555Hypodermic Safety Needle; Hypodermic Safety Needle with Syringe K202188Safety Blood Collection Sets for Single Use K222124Sterile Hypodermic Syringe with/without Needle, Hypodermic Needle K220900Safety Blood Collection Needles with/without Needle Holder K220083LDV((Low Dead Volume )Syringe

View all 12 devices →

Related Devices (Code: JKA)

K162233Kurin Blood Culture Collection SetPathway, LLC K160657BD Vacutainer Barricor Lithium Heparin Plasma Blood Collection TubeBecton, Dickinson and Company K153309BD Vacutainer UltraTouch Push Button Blood Collection SetBecton, Dickinson and Company K152924TIVA¿Velano Vascular K163073Sol-Care Safety Blood Collection Needle with and without Pre-Attached HolderSol-Millennium Medical, Inc. K163508PIVOVelano Vascular

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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