Cleared Traditional

K123684 - SOL-CARE SAFETY NEEDLE

K123684 is an FDA 510(k) clearance for SOL-CARE SAFETY NEEDLE, manufactured by Sol-Millennium Medical. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 159-day FDA review.

K123684 · Sol-Millennium Medical · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2013
Decision
159d
Days
Class 2
Risk

K123684 is an FDA 510(k) clearance for the SOL-CARE SAFETY NEEDLE. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Sol-Millennium Medical (Lawrenceville, US). The FDA issued a Cleared decision on May 8, 2013 after a review of 159 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Sol-Millennium Medical devices

FDA 510(k) Submission Details - K123684

510(k) Number K123684 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 2012
Decision Date May 08, 2013
Days to Decision 159 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 129d · This submission: 159d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMI Device Classification - Class 2, Special Controls

Product Code FMI Needle, Hypodermic, Single Lumen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FMI Needle, Hypodermic, Single Lumen

All 318
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K123684.
K-PACK II NEEDLE - 27G X 3/4 THIN WALL
K132233 · Terumo Europe N.V. · Sep 2013
STERICAN CANNULA
K131842 · B.Braun Medical, Inc. · Aug 2013
BD PEN NEEDLE
K131358 · Becton, Dickinson & CO · Jul 2013
BD PEN NEEDLE
K123300 · Becton, Dickinson & CO · Jan 2013
NIPRO HUBER INFUSION, EXCEL HUBER NEEDLE
K113469 · Nipro Medical Corporation · Oct 2012
THE T.A.L.O.N. INTRAOSSOUS INFUSION SYSTEM BY VIDACRE
K120661 · Vidacare Corporation · Jun 2012