Class Class II

Luer Lock Syringe with Safety Needle; Luer Lock Syringe with Exchangeable Needle; Luer Lock Syringe with Blunt Fill Needle (K241821)

K241821 2024-09-20 Traditional
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Description

Luer Lock Syringe with Safety Needle; Luer Lock Syringe with Exchangeable Needle; Luer Lock Syringe with Blunt Fill Needle by Sol-Millennium Medical, Inc., an FDA 510(k) cleared general hospital device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK241821
Clearance Date2024-09-20
Clearance TypeTraditional
Product CodeFMF
Regulation Number880.5860

Categories

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Predicate lineage for K241821

A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Luer Lock Syringe with Safety Needle; Luer Lock Syringe with Exchangeable Needle; Luer Lock Syringe with Blunt Fill Needle (K241821) cites 1 predicate device and is itself cited by 1 later device.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K221247Sterile Disposable Syringe with Safety Needle, Sterile Disp...Jiangsu Kangbao Medical Equipment C...2022

Later devices that cite this one as their predicate

Devices that cite K241821
K numberDeviceApplicantYear
K252184SOL-M Luer Lock Syringe with Exchangeable Needle TraySol-Millennium Medical, Inc.2026

Trace the full predicate network for K241821

A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.

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