Cleared Traditional

K112777 - SOL-M EXCHANGEABLE NEEDLES

K112777 is an FDA 510(k) clearance for SOL-M EXCHANGEABLE NEEDLES, manufactured by Sol-Milennium Medical, Inc.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K112777 · Sol-Milennium Medical, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2012
Decision
151d
Days
Class 2
Risk

K112777 is an FDA 510(k) clearance for the SOL-M EXCHANGEABLE NEEDLES. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Sol-Milennium Medical, Inc. (Dana Point, US). The FDA issued a Cleared decision on February 24, 2012 after a review of 151 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.

FDA 510(k) Submission Details - K112777

510(k) Number K112777 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2011
Decision Date February 24, 2012
Days to Decision 151 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 129d · This submission: 151d
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 633
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K112777.
PUSH-ON NEEDLE 30GX8MM
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VACUETTE QUICKSHIELD WITH SNAPPY TUBE HOLDER
K113505 · Greiner Bio-One North America, Inc. · Feb 2012
CLICKFINE AUTOPROTECT PEN NEEDLE
K110312 · Ypsomed AG · Jan 2012
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K112332 · Twobiens Co., Ltd. · Jan 2012
K112777 · SOL-M EXCHANGEABLE NEEDLES
Download PDF FDA Summary Sol-Milennium Medical…