# K053000: Haemonetics Cardiovascular Perioperative Autotransfusion System (Cardiopat)

- Pathway: 510(k) (Special)
- Applicant: Haemonetics Corp.
- Decided: Nov 21, 2005 after 27 days
- Product code: CAC (Apparatus, Autotransfusion)
- Device class: 2
- Regulation: 21 CFR 868.5830
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K043127 (2005). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043127: Haemonetics Cardiovascular Perioperative Autotransfusion System, Haemonetics Corp. (2005)

## Recalls of this device
- Jul 27, 2011 · Not classified · Z-2956-2011: Updated Operations Manual for the deployment of the spill collection system and cleaning
- Jan 25, 2011 · Not classified · Z-1391-2011: 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 remov
- Oct 15, 2007 · Not classified · Z-0358-2008: Labeling (additional) use instructions: to clarify proper position of cardioPAT device and post-op line to prevent fluid build up from patient's chest

## Indications for use
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.

Source page: https://510kreport.com/device/K053000
Methodology: https://510kreport.com/methodology