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FDA 510(k)

Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with Holder, Safety Blood Collecting Needle with Holder, Blood Collecting Set, Safety Blood Collecting Set, Blood Collecting Set with Holder, Safety Blood Collecting Set with Holder

K-Number: K172763 · 2018-06-04

ApplicantZhejiang Kindly Medical Devices Co., Ltd.
Decision Date2018-06-04
Product CodeJKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with Holder, Safety Blood Collecting Needle with Holder, Blood Collecting Set, Safety Blood Collecting Set, Blood Collecting Set with Holder, Safety Blood Collecting Set with Holder is a medical device manufactured by Zhejiang Kindly Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2018-06-04 under approval number K172763. 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 Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with Holder, Safety Blood Collecting Needle with Holder, Blood Collecting Set, Safety Blood Collecting Set, Blood Collecting Set with Holder, Safety Blood Collecting Set with Holder?

Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with Holder, Safety Blood Collecting Needle with Holder, Blood Collecting Set, Safety Blood Collecting Set, Blood Collecting Set with Holder, Safety Blood Collecting Set with Holder is a medical device that received FDA 510(k) clearance on 2018-06-04. It is manufactured by Zhejiang Kindly Medical Devices Co., Ltd.. The 510(k) number is K172763.

When was Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with Holder, Safety Blood Collecting Needle with Holder, Blood Collecting Set, Safety Blood Collecting Set, Blood Collecting Set with Holder, Safety Blood Collecting Set with Holder approved by the FDA?

Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with Holder, Safety Blood Collecting Needle with Holder, Blood Collecting Set, Safety Blood Collecting Set, Blood Collecting Set with Holder, Safety Blood Collecting Set with Holder received FDA 510(k) clearance on 2018-06-04, under approval number K172763.

What company makes Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with Holder, Safety Blood Collecting Needle with Holder, Blood Collecting Set, Safety Blood Collecting Set, Blood Collecting Set with Holder, Safety Blood Collecting Set with Holder?

Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with Holder, Safety Blood Collecting Needle with Holder, Blood Collecting Set, Safety Blood Collecting Set, Blood Collecting Set with Holder, Safety Blood Collecting Set with Holder is manufactured by Zhejiang Kindly Medical Devices Co., Ltd..

What is the FDA product code for Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with Holder, Safety Blood Collecting Needle with Holder, Blood Collecting Set, Safety Blood Collecting Set, Blood Collecting Set with Holder, Safety Blood Collecting Set with Holder?

The FDA product code for Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with Holder, Safety Blood Collecting Needle with Holder, Blood Collecting Set, Safety Blood Collecting Set, Blood Collecting Set with Holder, Safety Blood Collecting Set with Holder is JKA.

Related Clinical Trials

NCT07260890 Paired Comparison of SVV and PVI Accuracy COMPLETED NCT02193425 Reliability of the Human Brain Connectome COMPLETED NCT07615959 Medicsen Smartpatch: Safety & Performance (SOUNDD) ACTIVE_NOT_RECRUITING NCT07611721 Evaluate the Performance of the Dexcom G7 Continuous Glucose Monitoring (CGM) System in Critically Ill Patients Undergoing Major Abdominal Surgery and Solid Organ Transplantation Which Require Blood Glucose Monitoring for Intensive Insulin Therapy. RECRUITING NCT07383870 Clinical Evaluation of an AI- and Ultrasound-Assisted Venipuncture Device COMPLETED NCT07240818 Comparison of FNB to EUS-CNB for Pancreatic Lesions NOT_YET_RECRUITING

Related PubMed Literature

PMID: 41477286 Comparison of the Safety and Efficacy of Biodegradable Microneedle Acupuncture and Sterile Acupuncture: study protocol for a prospective, confirmatory, superiority, multicenter, parallel, single-blinded randomized controlled trial. Journal of pharmacopuncture (2025) PMID: 41322758 Real-World Case Series on Surgi-ORC® in ENT Surgery. Cureus (2025) PMID: 41085780 Evaluation of nickel release from Ni-Ti stents in various media for safety assessment purposes. Journal of materials science. Materials in medicine (2025)

Other Devices by Zhejiang Kindly Medical Devices Co., Ltd.

K181069Disposable Insulin Pen Needle K171518Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia Needles K223334Sterile Hypodermic Needles for Single Use K213183Safety Insulin Pen Needles

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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