Cleared Abbreviated

K100665 - MARROMAX B ONE MARROW ASPIRATION NEEDLE KIT, MODELS 50083-XX, 50084-XX

K100665 is an FDA 510(k) clearance for MARROMAX B ONE MARROW ASPIRATION NEEDLE KIT, manufactured by Needle Tech Products, Inc.. The device is a Class 2 General Hospital device with product code FMF cleared through the Abbreviated 510(k) pathway after a 108-day FDA review.

K100665 · Needle Tech Products, Inc. · General Hospital
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Jun 2010
Decision
108d
Days
Class 2
Risk

K100665 is an FDA 510(k) clearance for the MARROMAX B ONE MARROW ASPIRATION NEEDLE KIT, MODELS 50083-XX, 50084-XX. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Needle Tech Products, Inc. (Attleboro, US). The FDA issued a Cleared decision on June 24, 2010 after a review of 108 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - 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 - K100665

510(k) Number K100665 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 2010
Decision Date June 24, 2010
Days to Decision 108 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 129d · This submission: 108d
Pathway characteristics
Standards-based clearance path.

FMF Device Classification - Class 2, Special Controls

Product Code FMF Syringe, Piston
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 - FMF Syringe, Piston

All 599
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K100665 · MARROMAX B ONE MARROW ASPIRATION NEEDLE KIT, MODELS 50083-XX, 50084-XX
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