Cleared Traditional

K071934 - MARROWSTIM CONCENTRATION KIT AND MARROWSTIM MINI CONCENTRATION KIT

K071934 is an FDA 510(k) clearance for MARROWSTIM CONCENTRATION KIT AND MARROW..., manufactured by Biomet Manufacturing Corp. The device is a Class 1 Hematology device with product code JQC cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K071934 · Biomet Manufacturing Corp · Hematology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K071934

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 113d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

JQC Device Classification - Class 1, General Controls

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.

Regulatory Peers - JQC Centrifuges (micro, Ultra, Refrigerated) For Clinical Use

All 37
Devices cleared under the same product code (JQC) and FDA review panel - the closest regulatory comparables to K071934.
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K071934 · MARROWSTIM CONCENTRATION KIT AND MARROWSTIM MINI CONCENTRATION KIT
Download PDF FDA Summary Biomet Manufacturing …