# K933400: Kendall Curity 100% Silicone Foley Catheter W/Temperature Sensor

- Pathway: 510(k) (Traditional)
- Applicant: Kendall Healthcare Products Co. Div.Of Tyco Health
- Decided: Nov 15, 1993 after 126 days
- Product code: KOD (Catheter, Urological)
- Device class: 2
- Regulation: 21 CFR 876.5130
- Recalls of this device: 17 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K042709: Dover Silver Temperature Sensing Foley Catheter (2005), 0 descendants of its own
- K990509: Oligon Foley Catheter (16 FR) #33816/Oligon Foley Catheter (18 FR) #33818 (1999), 0 descendants of its own

## Recalls of this device
- Apr 30, 2020 · Class II · Z-1989-2020: Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Failure to correctly measure patient body temperatures could lead to an incorrect di
- Apr 30, 2020 · Class II · Z-1993-2020: Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Failure to correctly measure patient body temperatures could lead to an incorrect di
- Apr 30, 2020 · Class II · Z-1986-2020: Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Failure to correctly measure patient body temperatures could lead to an incorrect di
- Apr 30, 2020 · Class II · Z-1991-2020: Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Failure to correctly measure patient body temperatures could lead to an incorrect di
- Apr 30, 2020 · Class II · Z-1994-2020: Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Failure to correctly measure patient body temperatures could lead to an incorrect di
- Apr 30, 2020 · Class II · Z-1985-2020: Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Failure to correctly measure patient body temperatures could lead to an incorrect di
- Apr 30, 2020 · Class II · Z-1990-2020: Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Failure to correctly measure patient body temperatures could lead to an incorrect di
- Apr 30, 2020 · Class II · Z-1992-2020: Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Failure to correctly measure patient body temperatures could lead to an incorrect di
- Apr 30, 2020 · Class II · Z-1987-2020: Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Failure to correctly measure patient body temperatures could lead to an incorrect di
- Apr 30, 2020 · Class II · Z-1984-2020: Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Failure to correctly measure patient body temperatures could lead to an incorrect di
- Apr 30, 2020 · Class II · Z-1988-2020: Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Failure to correctly measure patient body temperatures could lead to an incorrect di
- Jul 11, 2018 · Class II · Z-3207-2018: The temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient.
- Jul 11, 2018 · Class II · Z-3205-2018: The temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient.
- Jul 11, 2018 · Class II · Z-3206-2018: The temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient.
- Jul 11, 2018 · Class II · Z-3204-2018: The temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient.
- Jul 11, 2018 · Class II · Z-3208-2018: The temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient.
- Jul 11, 2018 · Class II · Z-3203-2018: The temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient.

Source page: https://510kreport.com/device/K933400
Methodology: https://510kreport.com/methodology