Cleared Special

K092430 - 1 ML FIXED NEEDLE, 3 ML LUER LOCK, 5 ML LUER LOCK, 10 ML LUER LOCK, 20 ML LUERL LOCK SAFETY SYRINGES

K092430 is an FDA 510(k) clearance for 1 ML FIXED NEEDLE, manufactured by Inviro Medical Devices, Inc.. The device is a Class 2 General Hospital device with product code MEG cleared through the Special 510(k) pathway after a 28-day FDA review.

K092430 · Inviro Medical Devices, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2009
Decision
28d
Days
Class 2
Risk

K092430 is an FDA 510(k) clearance for the 1 ML FIXED NEEDLE, 3 ML LUER LOCK, 5 ML LUER LOCK, 10 ML LUER LOCK, 20 ML LUE.... Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by Inviro Medical Devices, Inc. (Lawrenceville, US). The FDA issued a Cleared decision on September 4, 2009 after a review of 28 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K092430

510(k) Number K092430 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2009
Decision Date September 04, 2009
Days to Decision 28 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 129d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

MEG Device Classification - Class 2, Special Controls

Product Code MEG Syringe, Antistick
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
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 - MEG Syringe, Antistick

All 162
Devices cleared under the same product code (MEG) and FDA review panel - the closest regulatory comparables to K092430.
1ML UNITRACT 27G X 1/2 TUBERCULIN SYRINGE, MODEL 132BY2-1
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INVIROSNAP 50 AND 100 UNIT INSULIN SAFETY SYRINGES
K092413 · Inviro Medical Devices, Inc. · Sep 2009
1ML UNITRACT INSULIN SYRINGE 27G*1/2 , 1ML UNITRACT SYRINGE 29G*1/2
K080877 · Unilife Medical Solutions Limited · Oct 2008
ULTIMED ULTICARE SAFETY SYRINGE
K080600 · Ultimed, Inc. · Jun 2008
JIERUI SYRINGES AND NEEDLES
K072739 · Shandong Weigao Group Medical Polymer Co., Ltd. · Mar 2008
K092430 · 1 ML FIXED NEEDLE, 3 ML LUER LOCK, 5 ML LUER LOCK, 10 ML LUER LOCK, 20 ML LUERL LOCK SAFETY SYRINGES
Download PDF FDA Summary Inviro Medical Device…