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Sjm Confirm Model DM2100 Implantable Cardiac Monitor and Model DM2100A Patient Activator

by St Jude Medical

510(k) K081365

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK081365 Date15 Aug 2008ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2733-2011 FDA Unclassified (pre-2012) initiated 31 Mar 2011

    The recall was initiated because St. Jude Medical made new software available for the SJM Confirm DM2100 implantable cardiac monitor (ICM) that incorporates enhancements to the devices sensing algorithm. These enhancements are intended to provide improved sensitivity and specificity for diagnosing arrhythmias. The user is presented with the option to upgrade new software into the SJM Confirm ICM

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  • Withdrawn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
MXC
Device Class
Class II
Regulation
21 CFR Part 870.2800
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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