510(k) · Cleared
Recalled · Class II · 2019CATSmart
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fresenius Kabi AG · CAC Apparatus, Autotransfusion
Cleared on Dec 10, 2018 as substantially equivalent to K971274 (Fresenius AG, 1997) after a 255-day review. Its family tree reaches back 1 generation to 1997. 2 later devices descend from it. It has been recalled once.
- Decided
- Dec 10, 2018
- Review
- 255 days
- Class
- Class II
- Product code
- CAC
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K971274 (1997). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK971274 C.a.T.S Continuous Autotransfusion System, AT1 Autotransfusion Set…Fresenius AG · 1997
- This deviceK180831 CATSmartFresenius Kabi AG · 2018
- Descendant · cites it directly · 1 of its ownK192368 CATSmartFresenius Kabi AG · 2019
- Descendant · 2 generations on · 0 of its ownK210089 CATSmart, Automated Blood Processing Autotransfusion SystemFresenius Kabi AG · 2021
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K971274 | C.a.T.S Continuous Autotransfusion System, AT1 Autotransfusion Set, PSQ Set | Fresenius AG | 1997 | — |
| 0 (this device) | K180831 | CATSmart | Fresenius Kabi AG | 2018 | — |
| +1 | K192368 | CATSmart | Fresenius Kabi AG | 2019 | — |
| +2 | K210089 | CATSmart, Automated Blood Processing Autotransfusion System | Fresenius Kabi AG | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2021 | 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? (1)
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 |
|---|---|---|---|
| * | K971274 | C.a.T.S Continuous Autotransfusion System, AT1 Autotransfusion Set, PSQ SetSummary page 4…C.A.T.S. Continuous Autotransfusion System Common or Usual Name: Automated Blood Processing Autotranfusion System 510(k) Number: K971274 Date Cleared: June 13, 1997 Product Code: CAC Device Class:… | 1997 |
| † | K160735 | CATSmart | 2016 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192368 | CATSmart | 2019 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 11, 2019 | Class II | Z-1059-2019 | Software design | The optional Vacuum Unit may stop working and display the failure message "Failure vacuum unit" during use. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K192368 (Fresenius Kabi AG, 2019) has gone furthest, with 1 descendant of its own.
How does its category compare?
All CAC devicesCAC Apparatus, Autotransfusion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
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 CATSmart System by Fresenius Kabi is an autotransfusion device indicated 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 Rich Plasma (PRP).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180831 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180831: CATSmart.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180831
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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