510(k) · Cleared
ClearedIbm 2991 Blood Cell Processor Mod. 1 & 2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intl. Business Machines · CAC Apparatus, Autotransfusion
Cleared on Sep 9, 1981 after a 21-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.
- Decided
- Sep 9, 1981
- Review
- 21 days
- Class
- Class II
- Product code
- CAC
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK812355 Ibm 2991 Blood Cell Processor Mod. 1 & 2Intl. Business Machines · 1981
- Descendant · cites it directly · 0 of its ownK982660 Orthopedic Perioperative Autotransfusion (Orthopat) SystemTransfusion Technologies Corp. · 1999
- Descendant · cites it directly · 0 of its ownK962475 Orthopedic Perioperative Autotransfusion (Orthopat) SystemTransfusion Technologies Corp. · 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) | K812355 | Ibm 2991 Blood Cell Processor Mod. 1 & 2 | Intl. Business Machines | 1981 | — |
| +1 | K982660 | Orthopedic Perioperative Autotransfusion (Orthopat) System | Transfusion Technologies Corp. | 1999 | — |
| +1 | K962475 | Orthopedic Perioperative Autotransfusion (Orthopat) System | Transfusion Technologies Corp. | 1997 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K982660 (Transfusion Technologies Corp., 1999) 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/K812355 · printed Nov 4, 2026
Cite this page
510(k) Report. “K812355: Ibm 2991 Blood Cell Processor Mod. 1 & 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K812355
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026