510(k) · Cleared
Recalled · Class II · 2021Signal Gear Urethral Catheter Electrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neurovision Medical Products, Inc. · FAP Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
Cleared on Dec 13, 2012 as substantially equivalent to K874758 (Dantec Electronics, Inc., 1988) after a 357-day review. Its family tree reaches back 1 generation to 1988. It has been recalled 2 times.
- Decided
- Dec 13, 2012
- Review
- 357 days
- Class
- Class II
- Product code
- FAP
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K874758 (1988). No later device cites it as a predicate yet.
- Root · 1 generation backK874758 Dantec 13L40 ST. Marks's Pudendal ElectrodeDantec Electronics, Inc. · 1988
- This deviceK113771 Signal Gear Urethral Catheter ElectrodeNeurovision Medical Products, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K874758 | Dantec 13L40 ST. Marks's Pudendal Electrode | Dantec Electronics, Inc. | 1988 | — |
| 0 (this device) | K113771 | Signal Gear Urethral Catheter Electrode | Neurovision Medical Products, Inc. | 2012 | — |
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 FAP? 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 |
|---|---|---|---|
| * | K874758 | Dantec 13L40 ST. Marks's Pudendal ElectrodeSummary page 1…vices The Signal Gear Urethral Catheter Electrode is substantially equivalent to the following predicate device previously distributed commercially in the U. S.: K874758 Dantec Electronic, Inc. St. Mark's Pudendal Electrode Device Description The Signal Gear Urethral Catheter Electrode is a single… | 1988 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 8, 2021 | Class II | Z-1968-2021 | Material/Component Contamination | The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization. |
| Apr 8, 2021 | Class II | Z-1970-2021 | Material/Component Contamination | The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All FAP devicesFAP Cystometric Gas (Carbon-Dioxide) On Hydraulic Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · FAP
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · FAP
Too few FAP 510(k)s in any year since 2007 to give a median.
Recalls per year · FAP
No recall names FAP since 2007.
Adverse event reports per year · FAP
36in 2025
MAUDE reports naming product code FAP, 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 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 36 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Signal Gear Urethral Catheter Electrode is intended for mucosal surface stimulation/recording from the external urinary sphincter for use in conjunction with urodynamic evaluation of the patient.
This device is indicated for use in adults, as well as in pediatric patients ages 2 and older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113771 · printed Nov 5, 2026
Cite this page
510(k) Report. “K113771: Signal Gear Urethral Catheter Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K113771
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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