Cleared Abbreviated

K072602 - VACUETTE PREMIUM SAFETY NEEDLE SYSTEM

K072602 is an FDA 510(k) clearance for VACUETTE PREMIUM SAFETY NEEDLE SYSTEM, manufactured by Medpro Safety Products, Inc.. The device is a Class 2 General Hospital device with product code FMI cleared through the Abbreviated 510(k) pathway after a 278-day FDA review.

K072602 · Medpro Safety Products, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2008
Decision
278d
Days
Class 2
Risk

K072602 is an FDA 510(k) clearance for the VACUETTE PREMIUM SAFETY NEEDLE SYSTEM. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Medpro Safety Products, Inc. (Lexington, US). The FDA issued a Cleared decision on June 18, 2008 after a review of 278 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K072602

510(k) Number K072602 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2007
Decision Date June 18, 2008
Days to Decision 278 days
Submission Type Abbreviated
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
149d slower than avg
Panel avg: 129d · This submission: 278d
Pathway characteristics
Standards-based clearance path.

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 632
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K072602.
NOVAGUARD, MODEL 3611001
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K080904 · Feel Tech · Jun 2008
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K080235 · Greiner Bio-One Vacuette North America · Apr 2008
FAST1 INTRAOSSEOUS INFUSION SYSTEM
K080865 · Pyng Medical Corp. · Apr 2008
K072602 · VACUETTE PREMIUM SAFETY NEEDLE SYSTEM
Download PDF FDA Summary Medpro Safety Product…