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Genius 2 Infrared Tympanic Electronic Thermometer, Model 303000

by Tyco Healthcare Group LP

510(k) K060649

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

5 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 NumberK060649 Date22 May 2006ClearedStatusActive

Recalls

5 recalls · FDA

  • 5 recalls, same reason

    • Terminated Z-0992-2020 FDA Class II initiated 28 Oct 2019
    • Terminated Z-0993-2020 FDA Class II initiated 28 Oct 2019
    • Terminated Z-0994-2020 FDA Class II initiated 28 Oct 2019
    • Terminated Z-0990-2020 FDA Class II initiated 28 Oct 2019
    • Terminated Z-0991-2020 FDA Class II initiated 28 Oct 2019

    The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manual may not ensure that thermometers always remain within the stated accuracy range ( 0.2C for Genius 2 and 0.3C for Genius 3 thermometers). The measurement readings drift upwards over time, which means that the thermometers could exceed the upper stated accuracy tolerance of +0.2C for Genius 2 or +0.3C for Genius 3.

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  • Withdrawn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
FLL
Device Class
Class II
Regulation
21 CFR Part 880.2910
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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