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Orthopedic Perioperative Autotransfusion (Orthopat) System

by Transfusion Technologies Corp. 3 variants

510(k) K982660

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK982660 Date30 Mar 1999ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
CAC
Device Class
Class II
Regulation
21 CFR Part 868.5830
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Orthopedic Perioperative Autotransfusion (Orthopat) System is an autotransfusion apparatus designed for use during major orthopedic surgical procedures. It collects shed blood, separates and washes red blood cells, and returns the processed autologous blood to the patient intra‑operatively or immediately post‑operatively.

The system is supplied as a complete perioperative autotransfusion set intended for joint replacement, spinal fusion and similar orthopedic surgeries, with a processing capacity of up to two liters per hour. It is classified as a Class II device and received FDA 510(k) clearance (K982660) as a substantially equivalent apparatus.

Other devices from Transfusion Technologies Corp.