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Power Processor Sample Processing System With Generic Connections

by Beckman Coulter, Inc.

510(k) K110413

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK110413 Date11 May 2011ClearedStatusActive

Recalls

2 recalls · 1 ongoing · FDA

    • Ongoing Z-0117-2022 FDA Class II initiated 28 Jul 2021

    Missing splash guard which may expose users to hazardous materials. .

    • Terminated Z-0046-2018 FDA Class II initiated 3 Aug 2017 on shared 510(k) K110413

    Beckman Coulter has identified that due to a PLC software nonconformity the 1K Stockyard can initiate a retrieval of a sample tube during the rack loading process, which should not occur. This issue and associated complaint were discovered and filed internally.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
CDD
Device class
Class II
Regulation
21 CFR Part 862.1810
Advisory committee
Clinical Chemistry
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 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 Power Processor Sample Processing System With Generic Connections is a sample handling system designed for in vitro diagnostic use. It automates pre-analytical testing processes to enhance laboratory productivity, accuracy, and consistency while reducing labor costs and minimizing opportunities for error.

The system can be configured with optional software and hardware to process sample tubes on Generic Connection Instruments (non-LX/DxC and IDC). It is supplied as laboratory equipment for use in clinical chemistry settings and has received FDA 510(k) clearance under product code CDD, with clearance based on substantial equivalence to a predicate device.

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Questions

AI-generated answers, 24 Sep 2026

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

  • What is the Power Processor Sample Processing System With Generic Connections used for?

    It is a sample handling system designed for in vitro diagnostic use that automates pre-analytical testing processes to improve laboratory productivity, accuracy, and consistency while reducing labor costs and minimizing errors in clinical chemistry settings.

  • How is the Power Processor Sample Processing System supplied and configured?

    It is supplied as laboratory equipment and can be configured with optional software and hardware to process sample tubes on Generic Connection Instruments (non-LX/DxC and IDC), allowing flexibility in laboratory workflow integration.

  • Is the Power Processor Sample Processing System a single-use or reusable device?

    The system is reusable laboratory equipment intended for repeated use in clinical chemistry settings; it is not a single-use disposable device, as it is designed to automate ongoing sample processing workflows.

  • What regulatory pathway was used for the Power Processor Sample Processing System?

    It received FDA 510(k) clearance under product code CDD, with the determination of substantial equivalence to a predicate device, as indicated by the decision code SESE and clearance type Special.