# K052925: SMARTPREP2 Centrifuge System

- Pathway: 510(k) (Traditional)
- Applicant: Harvest Technologies, Corp.
- Decided: Jan 4, 2006 after 78 days
- Product code: JQC (Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use)
- Device class: 1
- Regulation: 21 CFR 862.2050
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K991430 (1999). 1 ancestor in all.
3 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991430: Smartprep Centrifuge System, Harvest Technologies, LLC (1999) Summary page 4.
- (no number) Other table-top centrifuges previously cleared by the FDA via the 510(k) Notification process: named in the summary without a submission number

## Most influential descendants
- K250518: SMART M-CELL Bone Marrow Concentration System (2026), 0 descendants of its own
- K250516: SMART M-CELL PRP Concentration System (2026), 0 descendants of its own
- K081345: Axp Platform Marrow Xpress System Model 8-5137, 8-5138, 8-5139, 8-5140 (Primary) (2008), 0 descendants of its own

## Recalls of this device
- Oct 20, 2017 · Class II · Z-0103-2018: The patient labels included in the BMAC system procedure packs, catalog numbers 51416 and 51423, are printed with an incorrect lot number, catalog number, and expiry date; the lot number on the proced
- Oct 20, 2017 · Class II · Z-0104-2018: The patient labels included in the BMAC system procedure packs, catalog numbers 51416 and 51423, are printed with an incorrect lot number, catalog number, and expiry date; the lot number on the proced

## Indications for use
The SmartPReP2 Centrifuge System is 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/K052925
Methodology: https://510kreport.com/methodology