# K122262: Orthopat Advance Perioperative Autotransfusion System

- Pathway: 510(k) (Traditional)
- Applicant: Haemonetics Corp.
- Decided: Oct 25, 2012 after 90 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
Longest line of descent: 2 generations back to K910238 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992723: Orthopedic Perioperative Autotransfusion (Orthopat) System, Transfusion Technologies Corp. (1999) Summary page 3.

## Recalls of this device
- Jul 13, 2018 · Class II · Z-2951-2018: OrthoPAT¿ reservoirs are missing the cannula inside the reservoirs. The absence of this cannula prevents the emptying of blood from the reservoirs. The inability to empty the reservoir means that the 

## Indications for use
The Haemonetics OrthoPAT advance (Orthopedic Perioperative Autotransfusion) System is indicated for use to salvage Red Blood Cells (RBCs) from blood lost intraoperatively and postoperatively during surgical procedures where the expected rate of processing of salvaged blood and fluid aspirated from the surgical site is less than or equal to 2 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 RBC 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/K122262
Methodology: https://510kreport.com/methodology