# K071934: Marrowstim Concentration Kit and Marrowstim Mini Concentration Kit

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Manufacturing Corp
- Decided: Oct 11, 2007 after 90 days
- Product code: JQC (Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use)
- Device class: 1
- Regulation: 21 CFR 862.2050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Recalls of this device
- Mar 5, 2009 · Not classified · Z-1207-2009: A 30 ml tube is packaged with the kit instead of the labeled 60 ml tube.

## Indications for use
The MarrowStimTM Concentration Kit and the MarrowStimTM Mini Concentration Kit are intended to be used in the clinical laboratory or intraoperatively at point-of-care for the safe and rapid preparation of platelet poor plasma and platelet concentrate from a small sample of blood and for preparation of a cell concentrate from bone marrow.

Source page: https://510kreport.com/device/K071934
Methodology: https://510kreport.com/methodology