Cleared Traditional

K071934 - MARROWSTIM CONCENTRATION KIT AND MARROWSTIM MINI CONCENTRATION KIT (FDA 510(k) Clearance)

Class I Hematology device.

K071934 · Biomet Manufacturing Corp · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2007
Decision
90d
Days
Class 1
Risk

K071934 is an FDA 510(k) clearance for the MARROWSTIM CONCENTRATION KIT AND MARROWSTIM MINI CONCENTRATION KIT. Classified as Centrifuges (micro, Ultra, Refrigerated) For Clinical Use (product code JQC), Class I - General Controls.

Submitted by Biomet Manufacturing Corp (Warsaw, US). The FDA issued a Cleared decision on October 11, 2007 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 862.2050 - the FDA hematology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Biomet Manufacturing Corp devices

Submission Details

510(k) Number K071934 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 2007
Decision Date October 11, 2007
Days to Decision 90 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 113d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JQC Centrifuges (micro, Ultra, Refrigerated) For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2050
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.