510(k) · Cleared
Recalled · 2005Haemonetics Cardiovascular Perioperative Autotransfusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Haemonetics Corp. · CAC Apparatus, Autotransfusion
Cleared on Jan 4, 2005 after a 53-day review. The FDA summary names its predicate without a number. 1 later device descends from it. It has been recalled once.
- Decided
- Jan 4, 2005
- Review
- 53 days
- Class
- Class II
- Product code
- CAC
- Recalls
- 1
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK043127 Haemonetics Cardiovascular Perioperative Autotransfusion SystemHaemonetics Corp. · 2005
- Descendant · cites it directly · 0 of its ownK053000 Haemonetics Cardiovascular Perioperative Autotransfusion System…Haemonetics Corp. · 2005 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K053000Haemonetics Cardiovascular Perioperative Autotransfusion System (Cardiopat)Haemonetics Corp. · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K043127 | Haemonetics Cardiovascular Perioperative Autotransfusion System | Haemonetics Corp. | 2005 | — |
| +1 | K053000 | Haemonetics Cardiovascular Perioperative Autotransfusion System (Cardiopat) | Haemonetics Corp. | 2005 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 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 |
|---|---|---|---|
| * | — | Haemonetics® Orthopedic Perioperative Autotransfusion System (OrthoPAT®) Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K053000 | Haemonetics Cardiovascular Perioperative Autotransfusion System (Cardiopat) | 2005 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 22, 2005 | Not classified | Z-0174-06 | Other | Blood clotting of patient post operative while on the cardioPAT Cardiovascular Perioperative Autotransfusion System |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K053000 (Haemonetics Corp., 2005) 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 Haemonetics® Cardiovascular Perioperative Autotransfusion System (cardioPAT ) is indicated for use to salvage red blood cells from blood lost intraoperatively and postoperatively during cardiovascular surgical procedures, where the expected rate of processing of salvaged blood and fluid aspirated from the surgical site is less than or equal to two liters per hour. Autotransfasion is indicated for patients who meet at least one of the following…
Read the full statement (162 words)
The Haemonetics® Cardiovascular Perioperative Autotransfusion System (cardioPAT ) is indicated for use to salvage red blood cells from blood lost intraoperatively and postoperatively during cardiovascular surgical procedures, where the expected rate of processing of salvaged blood and fluid aspirated from the surgical site is less than or equal to two liters per hour.
Autotransfasion is indicated for patients who meet at least one of the following criteria:
* The patient is expected to lose sufficient blood in the perioperative period, so as to require red blood cell transfusion, and autotransfusion will likely reduce or eliminate the need for allogeneic blood transfusion.
* Religious beliefs cause the patient to refuse allogeneic transfusion, but accept autologous transfusion.
* Compatible allogeneic blood is not available.
* The patient is unable to donate sufficient quantities of autologous blood prior to surgery to adequately cover the anticipated transfusion requirement.
* The patient or physician prefers perioperative autotransfusion rather than preoperative autologous donation or transfusion of allogeneic blood.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043127 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043127: Haemonetics Cardiovascular Perioperative Autotransfusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043127
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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