510(k) · Cleared
ClearedExac-Temp Foley Catheter and Clini-Temp Foley Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Deroyal · EYC Catheter, Upper Urinary Tract
Cleared on Jul 2, 2004 after a 36-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it.
- Decided
- Jul 2, 2004
- Review
- 36 days
- Class
- Class II
- Product code
- EYC
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK041416 Exac-Temp Foley Catheter and Clini-Temp Foley CatheterDeroyal · 2004
- Descendant · cites it directly · 0 of its ownK200757 Foley Catheter with Temperature SensorDeroyal Industries, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK061918 Foley Catheters with Temperature ProbeGE Healthcare · 2006
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) | K041416 | Exac-Temp Foley Catheter and Clini-Temp Foley Catheter | Deroyal | 2004 | — |
| +1 | K200757 | Foley Catheter with Temperature Sensor | Deroyal Industries, Inc. | 2020 | — |
| +1 | K061918 | Foley Catheters with Temperature Probe | GE Healthcare | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2020 | 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 EYC? 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 EYC device
- #1 K200757 Foley Catheter with Temperature Sensorscore 0.2 · 1 generation · no Class I recall
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K200757 (Deroyal Industries, Inc., 2020) has gone furthest, with 0 descendants of its own.
How does its category compare?
All EYC devicesEYC Catheter, Upper Urinary Tract: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EYC
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · EYC
Too few EYC 510(k)s in any year since 2007 to give a median.
Recalls per year · EYC
No recall names EYC since 2007.
Adverse event reports per year · EYC
15in 2025
MAUDE reports naming product code EYC, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 7 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 1 | — | 0 | 6 |
| 2021 | 0 | — | 0 | 6 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 26 |
| 2025 | 0 | — | 0 | 15 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
DeRoyal Exac-Temp and Clini-Temp Foley Catheter with Temperature Sensors are to be used 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/K041416 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041416: Exac-Temp Foley Catheter and Clini-Temp Foley Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041416
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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