# K081345: Axp Platform Marrow Xpress System Model 8-5137, 8-5138, 8-5139, 8-5140 (Primary)

- Pathway: 510(k) (Abbreviated)
- Applicant: Thermogenesis Corp.
- Decided: Jul 10, 2008 after 57 days
- Product code: JQC (Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use)
- Device class: 1
- Regulation: 21 CFR 862.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K991430 (1999). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052925: SMARTPREP2 Centrifuge System, Harvest Technologies, Corp. (2006) Summary page 4.

## Indications for use
The AXP Platform MarrowXpress System is intended to be used in the clinical laboratory or intraoperatively at the point of care for preparation of a cell concentrate from bone marrow.

Source page: https://510kreport.com/device/K081345
Methodology: https://510kreport.com/methodology