Skip to content

Kendall Curity 100% Silicone Foley Catheter W/Temperature Sensor

by Kendall Healthcare Products Co. Div.Of Tyco Health

510(k) K933400

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

17 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 NumberK933400 Date15 Nov 1993ClearedStatusActive

Recalls

17 recalls · FDA

  • 11 recalls, same reason

    • Terminated Z-1984-2020 FDA Class II initiated 30 Apr 2020
    • Terminated Z-1985-2020 FDA Class II initiated 30 Apr 2020
    • Terminated Z-1988-2020 FDA Class II initiated 30 Apr 2020
    • Terminated Z-1990-2020 FDA Class II initiated 30 Apr 2020
    • Terminated Z-1991-2020 FDA Class II initiated 30 Apr 2020
    • Terminated Z-1994-2020 FDA Class II initiated 30 Apr 2020
    • Terminated Z-1987-2020 FDA Class II initiated 30 Apr 2020
    • Terminated Z-1989-2020 FDA Class II initiated 30 Apr 2020
    • Terminated Z-1993-2020 FDA Class II initiated 30 Apr 2020
    • Terminated Z-1986-2020 FDA Class II initiated 30 Apr 2020
    • Terminated Z-1992-2020 FDA Class II initiated 30 Apr 2020

    Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2C. Failure to correctly measure patient body temperatures could lead to an incorrect diagnosis and insufficient treatment

  • 6 recalls, same reason

    • Terminated Z-3205-2018 FDA Class II initiated 11 Jul 2018
    • Terminated Z-3203-2018 FDA Class II initiated 11 Jul 2018
    • Terminated Z-3208-2018 FDA Class II initiated 11 Jul 2018
    • Terminated Z-3204-2018 FDA Class II initiated 11 Jul 2018
    • Terminated Z-3206-2018 FDA Class II initiated 11 Jul 2018
    • Terminated Z-3207-2018 FDA Class II initiated 11 Jul 2018

    The temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient.

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  • Withdrawn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
KOD
Device Class
Class II
Regulation
21 CFR Part 876.5130
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Other devices from Kendall Healthcare Products Co. Div.Of Tyco Health

See all devices from Kendall Healthcare Products Co. Div.Of Tyco Health →