510(k) · Cleared
ClearedWell Lead Silicone Catheter with Temperature Sensor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Well Lead Medical Co., Ltd. · EZL Catheter, Retention Type, Balloon
Cleared on Oct 16, 2009 as substantially equivalent to K873448 (Respiratory Support Products, Inc., 1987) and 1 other predicate after a 147-day review. Its family tree reaches back 3 generations to 1990. 1 later device descends from it.
- Decided
- Oct 16, 2009
- Review
- 147 days
- Class
- Class II
- Product code
- EZL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K896053 (1990). 5 ancestors in all, the oldest K873448 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK896053 All Silicone Foley CatheterRochester Medical Corp. · 1990
- 2 generations backK981612 All Silicone Foley Catheter, Two-Way Foley Catheter, Three-Way Foley…Rochester Medical Corp. · 1998
- 1 generation backK082815 Well Lead Silicone and Latex Foley CathetersWell Lead Medical Instruments · 2008
- This deviceK091516 Well Lead Silicone Catheter with Temperature SensorWell Lead Medical Co., Ltd. · 2009
- Descendant · cites it directly · 0 of its ownK202134 Well Lead All Silicone Foley Catheter with Temperature SensorWell Lead Medical Co., Ltd. · 2021
Most influential descendants
Showing 1 of 1 · See all- K202134Well Lead All Silicone Foley Catheter with Temperature SensorWell Lead Medical Co., Ltd. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K896053 | All Silicone Foley Catheter | Rochester Medical Corp. | 1990 | — |
| −2 | K981612 | All Silicone Foley Catheter, Two-Way Foley Catheter, Three-Way Foley Catheter… | Rochester Medical Corp. | 1998 | — |
| −1 | K082815 | Well Lead Silicone and Latex Foley Catheters | Well Lead Medical Instruments | 2008 | — |
| 0 (this device) | K091516 | Well Lead Silicone Catheter with Temperature Sensor | Well Lead Medical Co., Ltd. | 2009 | — |
| +1 | K202134 | Well Lead All Silicone Foley Catheter with Temperature Sensor | Well Lead Medical Co., Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
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.
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? (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 |
|---|---|---|---|
| * | K873448 | Foley Catheter Temperature SensorSummary page 2…body core temperature during surgical or post- surgical intervals. Predicate Device: K873448 - Smiths Foley Catheter Temperature Sensor K082815 - Well Lead Silicone and… | 1987 |
| * | K082815 | Well Lead Silicone and Latex Foley CathetersSummary page 2…surgical intervals. Predicate Device: K873448 - Smiths Foley Catheter Temperature Sensor K082815 - Well Lead Silicone and Latex Foley Catheters Substantial Equivalence: Well Lead Medical Instrume… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K202134 | Well Lead All Silicone Foley Catheter with Temperature Sensor | 2021 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 8.4 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K202134 (Well Lead Medical Co., Ltd., 2021) 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. 2009, this device’s year, is highlighted.
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 Well Lead All Silicone Foley Catheters With Temperature Sensor 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091516 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091516: Well Lead Silicone Catheter 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/K091516
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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