510(k) · Cleared
ClearedFoley Catheter with Temperature Sensor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Deroyal Industries, Inc. · EYC Catheter, Upper Urinary Tract
Cleared on Oct 15, 2020 as substantially equivalent to K041416 (Deroyal, 2004) after a 205-day review. Its family tree reaches back 1 generation to 2004.
- Decided
- Oct 15, 2020
- Review
- 205 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 deviceK200757 Foley Catheter with Temperature SensorDeroyal Industries, Inc. · 2020
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) | K200757 | Foley Catheter with Temperature Sensor | Deroyal Industries, Inc. | 2020 | — |
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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 4…EXAC-TEMP Foley Catheter and CLINI-TEMP Foley Catheter [K041416] K200757… | 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. 2020, this device’s year, is highlighted.
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?
The DeRoyal Foley Catheter with Temperature Sensor is to be used for drainage of the urinary bladder and simultaneous monitoring of core body temperature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200757 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200757: Foley 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/K200757
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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