# K962475: Orthopedic Perioperative Autotransfusion (Orthopat) System

- Pathway: 510(k) (Traditional)
- Applicant: Transfusion Technologies Corp.
- Decided: Feb 20, 1997 after 240 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 intended for use in major orthopedic surgical procedures, such as joint replacement or spinal fusion to salvage red blood cells lost during and after surgery. It processes the shed blood to separate and wash the red blood cells (RBCs) and make them available for autologous transfusion to the patient.

Source page: https://510kreport.com/device/K962475
Methodology: https://510kreport.com/methodology