# K063442: All Silicone Foley Catheter, 2-Way, 3-Way, with Temperature Sensor

- Pathway: 510(k) (Traditional)
- Applicant: Degania Silicone, Ltd.
- Decided: Mar 26, 2007 after 132 days
- Product code: EZL (Catheter, Retention Type, Balloon)
- Device class: 2
- Regulation: 21 CFR 876.5130
- Recalls of this device: 69 (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’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K172422: Kohli Urinary Drainage Catheter (2018), 0 descendants of its own
- K103371: Coude/ or Tiemann (2011), 0 descendants of its own

## Recalls of this device
- Mar 17, 2020 · Class II · Z-1780-2020: Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters.
- Mar 17, 2020 · Class II · Z-1787-2020: Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters.
- Mar 17, 2020 · Class II · Z-1786-2020: Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters.
- Mar 17, 2020 · Class II · Z-1784-2020: Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters.
- Mar 17, 2020 · Class II · Z-1781-2020: Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters.
- Mar 17, 2020 · Class II · Z-1779-2020: Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters.
- Mar 17, 2020 · Class II · Z-1788-2020: Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters.
- Mar 17, 2020 · Class II · Z-1785-2020: Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters.
- Mar 17, 2020 · Class II · Z-1782-2020: Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters.
- Mar 17, 2020 · Class II · Z-1783-2020: Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters.
- Mar 17, 2020 · Class II · Z-1789-2020: Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters.
- Dec 2, 2019 · Class II · Z-0809-2020: Temperature deviation did not meet release specifications
- Jun 21, 2018 · Class II · Z-2779-2018: The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
- Jun 21, 2018 · Class II · Z-2764-2018: The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
- Jun 21, 2018 · Class II · Z-2754-2018: The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
- Jun 21, 2018 · Class II · Z-2784-2018: The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
- Jun 21, 2018 · Class II · Z-2769-2018: The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
- Jun 21, 2018 · Class II · Z-2780-2018: The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
- Jun 21, 2018 · Class II · Z-2770-2018: The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
- Jun 21, 2018 · Class II · Z-2767-2018: The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
- Jun 21, 2018 · Class II · Z-2782-2018: The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
- Jun 21, 2018 · Class II · Z-2755-2018: The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
- Jun 21, 2018 · Class II · Z-2776-2018: The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
- Jun 21, 2018 · Class II · Z-2781-2018: The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
- Jun 21, 2018 · Class II · Z-2761-2018: The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
- Jun 21, 2018 · Class II · Z-2759-2018: The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
- Jun 21, 2018 · Class II · Z-2758-2018: The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
- Jun 21, 2018 · Class II · Z-2783-2018: The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
- Jun 21, 2018 · Class II · Z-2756-2018: The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
- Jun 21, 2018 · Class II · Z-2775-2018: The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
- Jun 21, 2018 · Class II · Z-2766-2018: The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
- Jun 21, 2018 · Class II · Z-2778-2018: The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
- Jun 21, 2018 · Class II · Z-2762-2018: The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
- Jun 21, 2018 · Class II · Z-2777-2018: The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
- Jun 21, 2018 · Class II · Z-2774-2018: The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
- Jun 21, 2018 · Class II · Z-2773-2018: The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
- Jun 21, 2018 · Class II · Z-2757-2018: The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
- Jun 21, 2018 · Class II · Z-2760-2018: The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
- Jun 21, 2018 · Class II · Z-2772-2018: The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
- Jun 21, 2018 · Class II · Z-2771-2018: The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
- Jun 21, 2018 · Class II · Z-2785-2018: The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
- Jun 21, 2018 · Class II · Z-2768-2018: The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
- Jun 21, 2018 · Class II · Z-2763-2018: The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
- Jun 21, 2018 · Class II · Z-2765-2018: The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
- Jan 22, 2016 · Class II · Z-1220-2016: Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
- Jan 22, 2016 · Class II · Z-1224-2016: Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
- Jan 22, 2016 · Class II · Z-1228-2016: Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
- Jan 22, 2016 · Class II · Z-1211-2016: Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
- Jan 22, 2016 · Class II · Z-1219-2016: Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
- Jan 22, 2016 · Class II · Z-1215-2016: Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

## Indications for use
All Silicone Foley Catheter intended for urological use only. Foley Catheter 2-way: for routine drainage of the urinary bladder. Foley Catheter 3-way: for drainage of the urinary bladder and bladder irrigation. Foley Catheter with Temperature Sensor: for drainage of the urinary bladder and simultaneous monitoring of temperature.

Source page: https://510kreport.com/device/K063442
Methodology: https://510kreport.com/methodology