Cleared Abbreviated

K102010 - VACUETTE PREMIUM SAFETY BLOOD COLLECTION SET

K102010 is an FDA 510(k) clearance for VACUETTE PREMIUM SAFETY BLOOD COLLECTIO..., 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 126-day FDA review.

K102010 · Medpro Safety Products, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2010
Decision
126d
Days
Class 2
Risk

K102010 is an FDA 510(k) clearance for the VACUETTE PREMIUM SAFETY BLOOD COLLECTION SET. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Medpro Safety Products, Inc. (Lake Bluff, US). The FDA issued a Cleared decision on November 19, 2010 after a review of 126 days - within the typical 510(k) review window.

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.

View all Medpro Safety Products, Inc. devices

FDA 510(k) Submission Details - K102010

510(k) Number K102010 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2010
Decision Date November 19, 2010
Days to Decision 126 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 129d · This submission: 126d
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 328
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