510(k) · Cleared
Recalled · 2003Fresenius C.a.T.S; Ati Autotransfusion Set; PSQ Plasma Sequestration Set; PSQ-DD Plasma Sequestration Direct Draw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fresenius Hemotechnology, Inc. · CAC Apparatus, Autotransfusion
Cleared on Jul 23, 2001 after an 11-day review. The FDA summary names its predicate without a number. It has been recalled once.
- Decided
- Jul 23, 2001
- Review
- 11 days
- Class
- Class II
- Product code
- CAC
- Recalls
- 1
- Predicates
- 0
The FDA summary names its predicate without a number.
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.
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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 |
|---|---|---|---|
| * | — | Fresenius C.A.T.S Continuous Autotransfusion System AT Autotransfusion Set Named without a submission number | |
| * | — | Fresenius C.A.T.S Continuous Autotransfusion System Plasma Sequestration Set Named without a submission number | |
| * | — | Fresenius C.A.T.S Continuous Autotransfusion System Plasma Sequestration Direct Draw Set Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 21, 2003 | Not classified | Z-0906-03 | Other | Sterility may be compromised |
No ancestor or descendant has a Class I recall.
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 Fresenius AT1 Autotransfusion Set is a component of the C.A.T.S Continuous Autotransfusion System that is an Autotranfusion device for the processing of autologous shed blood collected intraoperatively and postoperatively to obtain washed packed red blood cells for reinfusion. The Fresenius Plasma Sequestration Set is a component of the C.A.T.S Continuous Autotransfusion System that is an Autotranfusion device for the processing of autologous shed…
Read the full statement (163 words)
The Fresenius AT1 Autotransfusion Set is a component of the C.A.T.S Continuous Autotransfusion System that is an Autotranfusion device for the processing of autologous shed blood collected intraoperatively and postoperatively to obtain washed packed red blood cells for reinfusion.
The Fresenius Plasma Sequestration Set is a component of the C.A.T.S Continuous Autotransfusion System that is an Autotranfusion device for the processing of autologous shed blood collected intraoperatively and postoperatively to obtain washed packed red blood cells for reinfusion. Additionally, it can be used for perioperative separation of blood into Packed Red Cells (PRC), Plasma (PLS) and Platelet Reich Plasma (PRP).
The Fresenius Plasma Sequestration Direction Draw Set is a component of the C.A.T.S Continuous Autotransfusion System that is an Autotranfusion device for the processing of autologous shed blood collected intraoperatively and postoperatively to obtain washed packed red blood cells for reinfusion. Additionally, it can be used for perioperative separation of biood into Packed Red Cells (PRC), Plasma (PLS) and Platelet Reich Plasma (PRP).
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/K012178 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012178: Fresenius C.a.T.S; Ati Autotransfusion Set; PSQ Plasma Sequestration Set; PSQ-DD Plasma Sequestration Direct Draw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012178
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Page last updated Nov 3, 2026