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FDA 510(k)

Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set

K-Number: K250907 · 2025-04-30

ApplicantSol-Millennium Medical, Inc.
Decision Date2025-04-30
Product CodeJKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set is a medical device manufactured by Sol-Millennium Medical, Inc.. It received FDA 510(k) clearance on 2025-04-30 under approval number K250907. 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 Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set?

Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set is a medical device that received FDA 510(k) clearance on 2025-04-30. It is manufactured by Sol-Millennium Medical, Inc.. The 510(k) number is K250907.

When was Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set approved by the FDA?

Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set received FDA 510(k) clearance on 2025-04-30, under approval number K250907.

What company makes Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set?

Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set is manufactured by Sol-Millennium Medical, Inc..

What is the FDA product code for Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set?

The FDA product code for Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set 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: 32192636 Food and Drug Administration's Perspective on Medical Devices Intended for Weight Loss: A Guide for the Interventional Radiologist. Techniques in vascular and interventional radiology (2020)

Other Devices by Sol-Millennium Medical, Inc.

K1620300.5ml Sol-Care Retractable Safety Syringe with Fixed Needle K153537Sol-M Insulin Syringe, Sol-M TB Syringe K163073Sol-Care Safety Blood Collection Needle with and without Pre-Attached Holder K182146Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Care Safety Blood Collection Needle with Holders, Sol-M Blood Collection Set K222744Sol-M Luer Lock Syringe K213718SOL-GUARD Safety Pull Button Collection Set

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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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