# K982660: Orthopedic Perioperative Autotransfusion (Orthopat) System

- Pathway: 510(k) (Traditional)
- Applicant: Transfusion Technologies Corp.
- Decided: Mar 30, 1999 after 243 days
- Product code: CAC (Apparatus, Autotransfusion)
- Device class: 2
- Regulation: 21 CFR 868.5830
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K812355 (1981). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910238: Portable Auto Transfusion System 500, Electromedics, Inc. (1991) Summary page 1.
- K812355: Ibm 2991 Blood Cell Processor Mod. 1 & 2, Intl. Business Machines (1981) Summary page 1.
- K913177: Solcotrans Orthopaedic Drainage/Reinfusion System, Solco Basle, Inc. (1993) Summary page 1.

## Indications for use
The OrthoPAT Orthopedic Perioperative Autotransfusion system is indicated for use to salvage RBCs from blood lost intraoperatively and postoperatively during orthopedic surgery procedures. Appropriate orthopedic procedures include joint replacement (primary and revision), and spinal fusion and instrumentation. 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/K982660
Methodology: https://510kreport.com/methodology