510(k) · Cleared
ClearedDover Silver Temperature Sensing Foley Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tyco Healthcare · EZL Catheter, Retention Type, Balloon
Cleared on Jan 18, 2005 as substantially equivalent to K933400 (Kendall Healthcare Products Co. Div.Of Tyco Health, 1993) and 1 other predicate after a 110-day review. Its family tree reaches back 1 generation to 1993. 1 of the 3 devices in its family, counting itself, has a Class I recall.
- Decided
- Jan 18, 2005
- Review
- 110 days
- Class
- Class II
- Product code
- EZL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K933400 (1993). 2 ancestors in all. No later device cites it as a predicate yet. 1 of the 3 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK933400 Kendall Curity 100% Silicone Foley Catheter W/Temperature SensorKendall Healthcare Products Co. Div.Of Tyco Health · 1993 · Recalled
- This deviceK042709 Dover Silver Temperature Sensing Foley CatheterTyco Healthcare · 2005
Class I recalls in this family
- K024010 Dover Silver Hydrogel Coated Silicone Foley…direct predicate · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K933400 | Kendall Curity 100% Silicone Foley Catheter W/Temperature Sensor | Kendall Healthcare Products Co. Div.Of Tyco Health | 1993 | 17 |
| 0 (this device) | K042709 | Dover Silver Temperature Sensing Foley Catheter | Tyco Healthcare | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 1 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. 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? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K933400 | Kendall Curity 100% Silicone Foley Catheter W/Temperature SensorSummary page 1…e sensor and DOVER®' Silver Hydro gel Coated Silicone Foley Catheter. DOVER® I00% Silicone Foley Catheter with Temperature sensor was cleared for marketing under 510O(k) K933400. DOVER® Silver Hydro gel Coated Silicone Foley Catheter was cleared for marketing under 510O(k) K02401 0. Confidential… | 1993 |
| * | K024010 | Dover Silver Hydrogel Coated Silicone Foley CatheterSummary page 1…r with Temperature sensor was cleared for marketing under 510O(k) K933400. DOVER® Silver Hydro gel Coated Silicone Foley Catheter was cleared for marketing under 510O(k) K02401 0. Confidential 237 Tyco Healthcare/Kendall DO VER®… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K024010Dover Silver Hydrogel Coated Silicone Foley CatheterThe Kendall Company Div. of Tyco Healthcare Group · 2003 · Direct predicate · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- 2 of the 2 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K933400.
How does its category compare?
All EZL devicesEZL Catheter, Retention Type, Balloon: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EZL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EZL
123in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EZL
2in 2024
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · EZL
1,381in 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?
The proposed catheters are intended for use in the drainage/collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgical or post-surgical intervals. General drainage is accomplished by inserting the catheter through the urethra and into the urine bladder. The catheter is retained in the bladder by inflation of balloon. Drainage is sometimes accomplished by suprapubic or other placement of the catheter.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042709 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042709: Dover Silver Temperature Sensing Foley Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042709
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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