# K043127: Haemonetics Cardiovascular Perioperative Autotransfusion System

- Pathway: 510(k) (Traditional)
- Applicant: Haemonetics Corp.
- Decided: Jan 4, 2005 after 53 days
- Product code: CAC (Apparatus, Autotransfusion)
- Device class: 2
- Regulation: 21 CFR 868.5830
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Haemonetics® Orthopedic Perioperative Autotransfusion System (OrthoPAT®): named in the summary without a submission number

## Most influential descendants
- K053000: Haemonetics Cardiovascular Perioperative Autotransfusion System (Cardiopat) (2005), 0 descendants of its own

## Recalls of this device
- Jul 22, 2005 · Not classified · Z-0174-06: Blood clotting of patient post operative while on the cardioPAT Cardiovascular Perioperative Autotransfusion System

## Indications for use
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.

Source page: https://510kreport.com/device/K043127
Methodology: https://510kreport.com/methodology