# K060482: Cytori Celution Cell Concentration Device

- Pathway: 510(k) (Traditional)
- Applicant: Cytori Therapeutics, Inc.
- Decided: Sep 28, 2006 after 217 days
- Product code: CAC (Apparatus, Autotransfusion)
- Device class: 2
- Regulation: 21 CFR 868.5830
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K884564 (1989). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972894: Autotransfusion Appartus (Autolog), Medtronic Blood Management (1998) Summary page 4.
- K020647: Dideco Electa, Dideco S.P.A. (2002) Summary page 4.
- K982650: Autologous Blood Management System (Abms), Dideco S.P.A. (1998) Summary page 4.

## Indications for use
The Cytori Celution Cell Concentration Device is indicated for the collection, concentration, washing, and reinfusion of autologous cells collected intraoperatively or postoperatively to obtain concentrated blood cells for reinfusion. Such areas of application may include, but are not limited to, the following: • General Surgery * Cardiovascular Surgery * Orthopedic Surgery * Vascular Surgery * Plastic/Reconstructive Procedures * Obstetric/Gynecologic Surgery * Neurosurgical Procedures * Thoracic Surgery * Transplantation Surgery * Emergency / Trauma Procedures * Urology Procedures Postoperative Treatment Areas

Source page: https://510kreport.com/device/K060482
Methodology: https://510kreport.com/methodology