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Dideco Electa Autotransfusion Apparatus

by Dideco S.P.A. 510(k)

Active United States

510(k) K020647

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Abbreviated NumberK020647 Date5 Sep 2002ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-1489-06 FDA Unclassified (pre-2012) initiated 4 Aug 2006
    • Terminated Z-1491-06 FDA Unclassified (pre-2012) initiated 4 Aug 2006

    Foreign particles-manufacturing error may lead to abrasion of bowl seal in blood recovery sets, possibly causing particles in the blood.

Specification

510(k)

Full name
Dideco Electa
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, 21 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 Dideco Electa is an autotransfusion apparatus designed for blood recovery and reinfusion. It consists of hardware and disposables, including a centrifuge, blood pump, automatic clamps, control and monitoring sensors, and a user interface with a display panel and keyboard.

The device is intended for single-use applications and is supplied sterile. It is not MRI safe. The device is regulated under 868.5830 and has received FDA 510(k) clearance (K020647) as substantially equivalent.

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