# K183205: PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System

- Pathway: 510(k) (Special)
- Applicant: Emcyte Corporation
- Decided: May 30, 2019 after 192 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
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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The PureBMC SupraPhysiologic Concentrating System is intended to be used in a clinical laboratory or intraoperatively at the point of care for the safe and rapid preparation of platelet concentrate and cell concentrate from a small sample of bone marrow aspirate. The safety and effectiveness of this device for in vivo indications for use has not been established.

Source page: https://510kreport.com/device/K183205
Methodology: https://510kreport.com/methodology