# K991430: Smartprep Centrifuge System

- Pathway: 510(k) (Traditional)
- Applicant: Harvest Technologies, LLC
- Decided: May 28, 1999 after 32 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
No predicates in its family tree.
7 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Predicate Centrifuge: named in the summary without a submission number

## Most influential descendants
- K052925: SMARTPREP2 Centrifuge System (2006), 3 descendants of its own
- K021902: Magellan Autologus Platelet Separator, MAG100, Magellan Autologous Platelet Separator Deisposable Kit, MKT300 (2002), 1 descendant of its own
- 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 Harvest SmartPReP™ CENTRIFUGE SYSTEM is designed 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. The plasma and concentrated platelets produced can be used for diagnostic tests.

Source page: https://510kreport.com/device/K991430
Methodology: https://510kreport.com/methodology