510(k) · Cleared
Recalled · Class II · 2020All Silicone Foley Catheter, 2-Way, 3-Way, with Temperature Sensor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Degania Silicone, Ltd. · EZL Catheter, Retention Type, Balloon
Cleared on Mar 26, 2007 after a 132-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it. It has been recalled 69 times.
- Decided
- Mar 26, 2007
- Review
- 132 days
- Class
- Class II
- Product code
- EZL
- Recalls
- 69
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK063442 All Silicone Foley Catheter, 2-Way, 3-Way, with Temperature SensorDegania Silicone, Ltd. · 2007
- Descendant · cites it directly · 0 of its ownK172422 Kohli Urinary Drainage CatheterNellie Medical, LLC · 2018
- Descendant · cites it directly · 0 of its ownK103371 Coude/ or TiemannDegania Silicone, Ltd. · 2011
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K063442 | All Silicone Foley Catheter, 2-Way, 3-Way, with Temperature Sensor | Degania Silicone, Ltd. | 2007 | — |
| +1 | K172422 | Kohli Urinary Drainage Catheter | Nellie Medical, LLC | 2018 | — |
| +1 | K103371 | Coude/ or Tiemann | Degania Silicone, Ltd. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2018 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EZL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new EZL device
- #1 K260756 TraumaGuard Intra-Abdominal Pressure-Sensing…score 13.2 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 17, 2020 | Class II | Z-1780-2020 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | Temperature deviation did not meet release specifications |
| Jun 21, 2018 | Class II | Z-2779-2018 | Employee error | 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 | Employee error | 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 | Employee error | 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 | Employee error | 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 | Employee error | 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 | Employee error | 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 | Employee error | 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 | Employee error | 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 | Employee error | 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 | Employee error | 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 | Employee error | 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 | Employee error | 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 | Employee error | 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 | Employee error | 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 | Employee error | 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 | Employee error | 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 | Employee error | 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 | Employee error | 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 | Employee error | 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 | Employee error | 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 | Employee error | 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 | Employee error | 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 | Employee error | 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 | Employee error | 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 | Employee error | 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 | Employee error | 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 | Employee error | 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 | Employee error | 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 | Employee error | 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 | Employee error | 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 | Employee error | 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 | Employee error | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria |
The 5 latest of 50 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K172422 (Nellie Medical, LLC, 2018) has gone furthest, with 0 descendants of its own.
How does its category compare?
All EZL devicesEZL Catheter, Retention Type, Balloon: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · EZL
1in 2025
2007high 9 (2018) · low 0 (2012)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · EZL
123in 2024
2007high 282 (2023) · low 114 (2009)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EZL
2in 2024
2007high 2 (2023) · low 0 (2007)2026
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · EZL
1,381in 2025
2007high 1,381 (2025) · low 6 (2008)2025
MAUDE reports naming product code EZL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 7 | 186 | 0 | 8 |
| 2008 | 2 | — | 0 | 6 |
| 2009 | 4 | 114 | 0 | 6 |
| 2010 | 1 | — | 0 | 27 |
| 2011 | 2 | — | 0 | 79 |
| 2012 | 0 | — | 0 | 65 |
| 2013 | 3 | 151 | 0 | 99 |
| 2014 | 2 | — | 0 | 229 |
| 2015 | 3 | 132 | 0 | 303 |
| 2016 | 1 | — | 0 | 326 |
| 2017 | 2 | — | 0 | 571 |
| 2018 | 9 | 177 | 0 | 677 |
| 2019 | 3 | 266 | 1 | 671 |
| 2020 | 4 | 137 | 0 | 712 |
| 2021 | 2 | — | 0 | 702 |
| 2022 | 2 | — | 0 | 884 |
| 2023 | 3 | 282 | 2 (2) | 772 |
| 2024 | 5 | 123 | 2 | 1,029 |
| 2025 | 1 | — | 0 | 1,381 |
| 2026 | 4 | 170 | 2 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K063442 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063442: All Silicone Foley Catheter, 2-Way, 3-Way, with Temperature Sensor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063442
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026