510(k) · Cleared
Recalled · 2011Haemonetics Cardiovascular Perioperative Autotransfusion System (Cardiopat)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Haemonetics Corp. · CAC Apparatus, Autotransfusion
Cleared on Nov 21, 2005 as substantially equivalent to K043127 (Haemonetics Corp., 2005) after a 27-day review. Its family tree reaches back 1 generation to 2005. It has been recalled 3 times.
- Decided
- Nov 21, 2005
- Review
- 27 days
- Class
- Class II
- Product code
- CAC
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 1 generation to K043127 (2005). No later device cites it as a predicate yet.
- Root · 1 generation backK043127 Haemonetics Cardiovascular Perioperative Autotransfusion SystemHaemonetics Corp. · 2005 · Recalled
- This deviceK053000 Haemonetics Cardiovascular Perioperative Autotransfusion System…Haemonetics Corp. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K043127 | Haemonetics Cardiovascular Perioperative Autotransfusion System | Haemonetics Corp. | 2005 | 1 |
| 0 (this device) | K053000 | Haemonetics Cardiovascular Perioperative Autotransfusion System (Cardiopat) | Haemonetics Corp. | 2005 | — |
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 |
|---|---|---|---|
| * | K043127 | Haemonetics Cardiovascular Perioperative Autotransfusion System | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 27, 2011 | Not classified | Z-2956-2011 | Component design/selection | Updated Operations Manual for the deployment of the spill collection system and cleaning |
| Jan 25, 2011 | Not classified | Z-1391-2011 | Labeling design | Update Instructions for Use for the CardioPAT® Manual for Leak Detection. User may mis-interpret the air-leak rate displayed by the cardioPAT device when making a determination about chest-drain removal, which could result in the patient… |
| Oct 15, 2007 | Not classified | Z-0358-2008 | Labeling design | Labeling (additional) use instructions: to clarify proper position of cardioPAT device and post-op line to prevent fluid build up from patient's chest |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
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 (cardioPATTM) 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. Autotransfusion is indicated for patients who meet at least one of the following…
Read the full statement (161 words)
The Haemonetics® Cardiovascular Perioperative Autotransfusion System (cardioPATTM) 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.
Autotransfusion 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/K053000 · printed Nov 3, 2026
Cite this page
510(k) Report. “K053000: Haemonetics Cardiovascular Perioperative Autotransfusion System (Cardiopat).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K053000
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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