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Newcor

by Siemens Medical Systems, Inc.

510(k) K020440

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

10 closed

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 NumberK020440 Date3 Dec 2002ClearedStatusActive

Recalls

10 recalls · FDA

    • Terminated Z-2688-2017 FDA Class II initiated 16 May 2017

    Software error. In Sensis Vibe systems with software version VD10B, a software error can result in: problems generating a report and/ or - information from different examinations of the same patient being combined into one report. --- The error causes information from two examinations to be combined into one report. This does not result in a hazardous situation; however, if the erroneous report has been used for treatment or diagnosis, this can potentially result in an incorrect treatment or diagnosis.

    • Terminated Z-2156-2017 FDA Class II initiated 12 Apr 2017

    An extremely dusty computer can cause problems at system start, or rarely, cause system fail. Perform a system check prior to performing exams. If the Sensis system fails, its functions can not be used. Clinical treatment may need to be terminated, restarted, or transferred to a functioning system.

    • Terminated Z-1506-2012 FDA Not yet classified initiated 22 Feb 2012

    There is a potential malfunction in the connection of a Sensis EP system with Carto(R) 3 dedicated cable set (part number 14411343) with the Carto 3 system from Bionsense Webster.

  • 5 recalls, same reason

    • Terminated Z-0036-05 FDA Unclassified (pre-2012) initiated 9 Jul 2004
    • Terminated Z-0033-05 FDA Unclassified (pre-2012) initiated 9 Jul 2004
    • Terminated Z-0035-05 FDA Unclassified (pre-2012) initiated 9 Jul 2004
    • Terminated Z-0034-05 FDA Unclassified (pre-2012) initiated 9 Jul 2004
    • Terminated Z-0032-05 FDA Unclassified (pre-2012) initiated 9 Jul 2004

    possible error calculating valve area with the AXIOM Sensis

    • Terminated Z-1446-04 FDA Unclassified (pre-2012) initiated 17 May 2004

    Software issue. Allows for users to enter date in Pre-Cath Holding Area prior to registering the patient in the Cath Lab.

    • Terminated Z-0979-03 FDA Unclassified (pre-2012) initiated 28 Feb 2003

    software problem - erroneous results or system crashes

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
DQK
Device Class
Class II
Regulation
21 CFR Part 870.1425
Advisory Committee
Cardiovascular
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 Newcor is a medical device manufactured by Siemens Medical Systems, Inc. It is classified under the product code DQK and has been found to be substantially equivalent to a predicate device. The device has a specific k number, K020440.

The Newcor is supplied by Siemens Medical Systems, Inc. and has received FDA 510K authorization. The device is associated with the Cardiovascular advisory committee and has a clearance type of Traditional. It is manufactured in the US, with a specific address and contact information available.

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