510(k) · Cleared
Recalled · 2005Brat 2 Autologus Blood Salvage System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cobe Cardiovascular, Inc. · CAC Apparatus, Autotransfusion
Cleared on Dec 29, 1993 after a 163-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it. It has been recalled 6 times.
- Decided
- Dec 29, 1993
- Review
- 163 days
- Class
- Class II
- Product code
- CAC
- Recalls
- 6
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK933625 Brat 2 Autologus Blood Salvage SystemCobe Cardiovascular, Inc. · 1993
- Descendant · cites it directly · 0 of its ownK974897 Cobe Brat 2 System with Modified Standard Volume Processing SetCobe Cardiovascular, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK973627 Standard Volume Processing Set for the Cobe Brat 2 Autologous Blood…Cobe Cardiovascular, Inc. · 1997
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 |
|---|---|---|---|---|---|
| 0 (this device) | K933625 | Brat 2 Autologus Blood Salvage System | Cobe Cardiovascular, Inc. | 1993 | — |
| +1 | K974897 | Cobe Brat 2 System with Modified Standard Volume Processing Set | Cobe Cardiovascular, Inc. | 1998 | — |
| +1 | K973627 | Standard Volume Processing Set for the Cobe Brat 2 Autologous Blood Salvage… | Cobe Cardiovascular, Inc. | 1997 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 22, 2005 | Not classified | Z-1072-05 | Other | Packaging trays may have holes in them as a result of the sealing process, which could compromise the sterility of the product. |
| Jun 22, 2005 | Not classified | Z-1070-05 | Other | Packaging trays may have holes in them as a result of the sealing process, which could compromise the sterility of the product. |
| Jun 22, 2005 | Not classified | Z-1069-05 | Other | Packaging trays may have holes in them as a result of the sealing process, which could compromise the sterility of the product. |
| Jun 22, 2005 | Not classified | Z-1071-05 | Other | Packaging trays may have holes in them as a result of the sealing process, which could compromise the sterility of the product. |
| Jun 22, 2005 | Not classified | Z-1073-05 | Other | Packaging trays may have holes in them as a result of the sealing process, which could compromise the sterility of the product. |
| Jun 22, 2005 | Not classified | Z-1074-05 | Other | Packaging trays may have holes in them as a result of the sealing process, which could compromise the sterility of the product. |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K974897 (Cobe Cardiovascular, Inc., 1998) has gone furthest, with 0 descendants 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.
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 | — |
https://510kreport.com/device/K933625 · printed Nov 6, 2026
Cite this page
510(k) Report. “K933625: Brat 2 Autologus Blood Salvage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K933625
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026