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Tempus Ic Professional Patient Monitor

by Remote Diagnostic Technologies Ltd.

510(k) K101264

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK101264 Date11 May 2010ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2183-2011 FDA Unclassified (pre-2012) initiated 25 Mar 2011

    It was discovered that when a 12 Lead ECG is recorded and monitoring is quickly restarted, the ECG can cease functioning.

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  • Withdrawn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
MWI
FDA applicant
Remote Diagnostic Technologies , Ltd.
Device Class
Class II
Regulation
21 CFR Part 870.2300
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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