510(k) · Cleared
ClearedCytori Celution Cell Concentration Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cytori Therapeutics, Inc. · CAC Apparatus, Autotransfusion
Cleared on Sep 28, 2006 as substantially equivalent to K972894 (Medtronic Blood Management, 1998) and 2 other predicates after a 217-day review. Its family tree reaches back 3 generations to 1989.
- Decided
- Sep 28, 2006
- Review
- 217 days
- Class
- Class II
- Product code
- CAC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K884564 (1989). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK884564 Shiley Therapeutic Autotransfusion System-ProgrammShiley, Inc. · 1989
- 2 generations backK982650 Autologous Blood Management System (Abms)Dideco S.P.A. · 1998 · Recalled
- 1 generation backK020647 Dideco ElectaDideco S.P.A. · 2002 · Recalled
- This deviceK060482 Cytori Celution Cell Concentration DeviceCytori Therapeutics, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K884564 | Shiley Therapeutic Autotransfusion System-Programm | Shiley, Inc. | 1989 | — |
| −2 | K982650 | Autologous Blood Management System (Abms) | Dideco S.P.A. | 1998 | 2 |
| −1 | K020647 | Dideco Electa | Dideco S.P.A. | 2002 | 2 |
| 0 (this device) | K060482 | Cytori Celution Cell Concentration Device | Cytori Therapeutics, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CAC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CAC device
- #1 K240426 Aventus Clot Management Systemscore 11.2 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K972894 | Autotransfusion Appartus (Autolog)Summary page 4…with the following predicate devices which have been determined by FDA to be substantially equivalent to pre-amendment devices: Medtronic Autolog Autotransfusion System (K972894), Dideco Electra (K020647), and Dideco Autologous Blood Management System (K982650). Indications For Use The Cytori Therapeutics… | 1998 |
| * | K020647 | Dideco ElectaSummary page 4…te devices which have been determined by FDA to be substantially equivalent to pre-amendment devices: Medtronic Autolog Autotransfusion System (K972894), Dideco Electra (K020647), and Dideco Autologous Blood Management System (K982650). Indications For Use The Cytori Therapeutics Celution Cell Concentrati… | 2002 |
| * | K982650 | Autologous Blood Management System (Abms)Summary page 4…ntially equivalent to pre-amendment devices: Medtronic Autolog Autotransfusion System (K972894), Dideco Electra (K020647), and Dideco Autologous Blood Management System (K982650). Indications For Use The Cytori Therapeutics Celution Cell Concentration Device and the predicate devices share substantially e… | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 4.1 years on median.
- 3 of the 9 ancestors have a recall of any class.
- 1 other device also cites its predicate K972894.
How does its category compare?
All CAC devicesCAC Apparatus, Autotransfusion: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CAC
3in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CAC
91in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CAC
7in 2023
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · CAC
128in 2025
MAUDE reports naming product code CAC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 1 | 35 |
| 2008 | 1 | — | 5 | 12 |
| 2009 | 0 | — | 25 | 68 |
| 2010 | 4 | 123 | 3 | 115 |
| 2011 | 2 | — | 3 | 939 |
| 2012 | 3 | 90 | 0 | 249 |
| 2013 | 1 | — | 9 | 153 |
| 2014 | 3 | 269 | 0 | 90 |
| 2015 | 0 | — | 0 | 87 |
| 2016 | 2 | — | 0 | 73 |
| 2017 | 1 | — | 2 | 88 |
| 2018 | 2 | — | 2 | 87 |
| 2019 | 1 | — | 23 | 64 |
| 2020 | 1 | — | 0 | 108 |
| 2021 | 4 | 155 | 0 | 73 |
| 2022 | 1 | — | 0 | 65 |
| 2023 | 2 | — | 7 (2) | 39 |
| 2024 | 3 | 91 | 0 | 129 |
| 2025 | 0 | — | 0 | 128 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K060482 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060482: Cytori Celution Cell Concentration Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060482
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026