510(k) · Cleared
ClearedCobe Brat 2 Autologous Blood Salvage System with Modified Plasma Recovery Program (PRP)
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 Jan 28, 1997 as substantially equivalent to K933960 (Cobe Cardiovascular, Inc., 1994) after a 201-day review. Its family tree reaches back 1 generation to 1994. 2 later devices descend from it.
- Decided
- Jan 28, 1997
- Review
- 201 days
- Class
- Class II
- Product code
- CAC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K933960 (1994). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK933960 Plasma Recovery Program for the Cobe Brat 2 Autologous Blood Salvage…Cobe Cardiovascular, Inc. · 1994
- This deviceK962689 Cobe Brat 2 Autologous Blood Salvage System with Modified Plasma…Cobe Cardiovascular, Inc. · 1997
- 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 |
|---|---|---|---|---|---|
| −1 | K933960 | Plasma Recovery Program for the Cobe Brat 2 Autologous Blood Salvage System | Cobe Cardiovascular, Inc. | 1994 | — |
| 0 (this device) | K962689 | Cobe Brat 2 Autologous Blood Salvage System with Modified Plasma Recovery… | Cobe Cardiovascular, Inc. | 1997 | — |
| +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), 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? (2)
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 |
|---|---|---|---|
| * | K933960 | Plasma Recovery Program for the Cobe Brat 2 Autologous Blood Salvage SystemSummary page 1…em with Modified Plasma Recovery Program (PRP) consists of a number of changes from the original Plasma Recovery Program for the COBE BRAT®2 approved per 510(k) number K933960. These changes include: ¢ Expanded volume delivery range of 25 to 200 ml/min for the fill cycle of PRP ¢ Addition of a manual m… | 1994 |
| * | — | Electromedics Autotransfusion Machine AT 500 Named without a submission number |
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 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 | — |
What is it indicated for?
The COBE BRAT 2 is indicated for use for recovery and/or processing of autologous blood.
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/K962689 · printed Nov 6, 2026
Cite this page
510(k) Report. “K962689: Cobe Brat 2 Autologous Blood Salvage System with Modified Plasma Recovery Program (PRP).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962689
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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