Cleared Special

K111424 - VACUETTE PREMIUM SAFETY NEEDLE SYSTEM TUBE-TOUCH

K111424 is an FDA 510(k) clearance for VACUETTE PREMIUM SAFETY NEEDLE SYSTEM T..., manufactured by Medpro Safety Products, Inc.. The device is a Class 2 General Hospital device with product code FMI cleared through the Special 510(k) pathway after a 67-day FDA review.

K111424 · Medpro Safety Products, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2011
Decision
67d
Days
Class 2
Risk

K111424 is an FDA 510(k) clearance for the VACUETTE PREMIUM SAFETY NEEDLE SYSTEM TUBE-TOUCH. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Medpro Safety Products, Inc. (Baldwin, US). The FDA issued a Cleared decision on July 29, 2011 after a review of 67 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - 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.

View all Medpro Safety Products, Inc. devices

FDA 510(k) Submission Details - K111424

510(k) Number K111424 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2011
Decision Date July 29, 2011
Days to Decision 67 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
62d faster than avg
Panel avg: 129d · This submission: 67d
Pathway characteristics
Modification to existing cleared device.

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 328
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K111424.
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