# K030340: Autologel Process Centrifuge, Model B4360 (100-103, 100-129)

- Pathway: 510(k) (Traditional)
- Applicant: Cytomedix
- Decided: Apr 11, 2003 after 70 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: 1 generation 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)
- K991430: Smartprep Centrifuge System, Harvest Technologies, LLC (1999) Summary page 1.
- K994148: 3I Model (S)7426 and 7427 Celsep Centrifuge System, Implant Innovations, Inc. (2000) Summary page 1.

## Indications for use
The AutoloGel Process Centrifuge is designed to be used at the patient’s point of care for the safe and rapid preparation of platelet-rich plasma (PRP) from a small sample of the patient’s blood (up to 60 mi).

Source page: https://510kreport.com/device/K030340
Methodology: https://510kreport.com/methodology