# K992723: Orthopedic Perioperative Autotransfusion (Orthopat) System

- Pathway: 510(k) (Traditional)
- Applicant: Transfusion Technologies Corp.
- Decided: Oct 18, 1999 after 66 days
- Product code: CAC (Apparatus, Autotransfusion)
- Device class: 2
- Regulation: 21 CFR 868.5830
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K910238 (1991). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 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.

## Most influential descendants
- K122262: Orthopat Advance Perioperative Autotransfusion System (2012), 0 descendants of its own

## Recalls of this device
- Jul 13, 2018 · Class II · Z-2950-2018: 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 
- Apr 29, 2011 · Not classified · Z-2420-2011: 2 Models Model 1: OrthoPAT devices with no centrifuge drain spill containment system may have potential for fluid contamination leading to potential spark or smoke may occur are recalled Model 2: Orth

## Indications for use
The OrthoPAT Perioperative Autotransfusion System is indicated for use to salvage RBCs from blood lost intraoperatively and postoperatively during surgical procedures where the expected rate of processing of salvaged blood ang 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/K992723
Methodology: https://510kreport.com/methodology