510(k) · Cleared
ClearedFoley Catheters with Temperature Probe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Healthcare · EYC Catheter, Upper Urinary Tract
Cleared on Aug 18, 2006 as substantially equivalent to K041416 (Deroyal, 2004) after a 43-day review. Its family tree reaches back 1 generation to 2004.
- Decided
- Aug 18, 2006
- Review
- 43 days
- Class
- Class II
- Product code
- EYC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K041416 (2004). No later device cites it as a predicate yet.
- Root · 1 generation backK041416 Exac-Temp Foley Catheter and Clini-Temp Foley CatheterDeroyal · 2004
- This deviceK061918 Foley Catheters with Temperature ProbeGE Healthcare · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K041416 | Exac-Temp Foley Catheter and Clini-Temp Foley Catheter | Deroyal | 2004 | — |
| 0 (this device) | K061918 | Foley Catheters with Temperature Probe | GE Healthcare | 2006 | — |
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 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? (1)
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 |
|---|---|---|---|
| * | K041416 | Exac-Temp Foley Catheter and Clini-Temp Foley CatheterSummary page 2…1024242 and M1024244) are substantially equivalent in safety and effectiveness to the predicate DeRoyal disposable Foley catheters with temperature sensor (K041416). DEVICE DESCRIPTION as required by 807.92(a)(4) Disposable Foley catheters with temperature probe are used for drainage… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K041416.
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?
Foley catheters with temperature probe (REF M1024239, M1024242 and M1024244): The Foley Catheter with Temperature Probe is intended for continuous temperature monitoring of patients who are catheterized because of fluid management problems, evaluation of urinary output, urine clearance following surgery or trauma involving pelvic organs, or obstruction or paralysis. Maximum indwelling: 29 days. The temperature probes are designed for use with…
Read the full statement (102 words)
Foley catheters with temperature probe (REF M1024239, M1024242 and M1024244):
The Foley Catheter with Temperature Probe is intended for continuous temperature monitoring of patients who are catheterized because of fluid management problems, evaluation of urinary output, urine clearance following surgery or trauma involving pelvic organs, or obstruction or paralysis. Maximum indwelling: 29 days.
The temperature probes are designed for use with Datex-Ohmeda and GE Medical Systems IT monitoring systems and other monitors compatible with 400 Series temperature probes. Please consult your monitoring system manual for information specific to temperature probes usage. The device is indicated for use by qualified medical personnel only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061918 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061918: Foley Catheters with Temperature Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061918
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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