510(k) Report

510(k) · Cleared

Cleared

Dantec 13L40 ST. Marks's Pudendal Electrode

K874758510(k) TraditionalCleared Apr 14, 1988148-day reviewClass II21 CFR 876.1620

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Dantec Electronics, Inc. · FAP Cystometric Gas (Carbon-Dioxide) On Hydraulic Device

Cleared on Apr 14, 1988 after a 148-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Apr 14, 1988
Review
148 days
Class
Class II
Product code
FAP
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2012: 1 descendant cleared1990200020102020
  1. This deviceK874758 Dantec 13L40 ST. Marks's Pudendal ElectrodeDantec Electronics, Inc. · 1988
  2. Descendant · cites it directly · 0 of its ownK113771 Signal Gear Urethral Catheter ElectrodeNeurovision Medical Products, Inc. · 2012 · Recalled

Most influential descendants

Showing 1 of 1 · See all
  • K113771Signal Gear Urethral Catheter ElectrodeNeurovision Medical Products, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K874758Dantec 13L40 ST. Marks's Pudendal ElectrodeDantec Electronics, Inc.1988—
+1K113771Signal Gear Urethral Catheter ElectrodeNeurovision Medical Products, Inc.20122

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
FIG. 1 — Lineage of K874758, 1988–2012Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K113771Signal Gear Urethral Catheter ElectrodeNeurovision Medical Products, Inc.20120

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, K113771 (Neurovision Medical Products, Inc., 2012) has gone furthest, with 0 descendants of its own.

How does its category compare?

All FAP devices

FAP Cystometric Gas (Carbon-Dioxide) On Hydraulic Device: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FAP

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2026

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

2009: 12016: 12018: 22024: 22025: 36
2007high 36 (2025) · low 0 (2007)2025

MAUDE reports naming product code FAP, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—01
20100—00
20110—00
20121—00
20130—00
20140—00
20150—00
20160—01
20170—00
20180—02
20190—00
20200—00
20210—00
20220—00
20230—00
20240—02
20250—036
20260—0—

More from Dantec Electronics, Inc.

12 FDA decisions under this applicant name. See the company

  • K895460Concentric Electrode Type #13R01, 13R02Dantec Electronics, Inc. · 1990
  • K894911Sensory Needle Electrode Dne 111-115,116-117,118Dantec Electronics, Inc. · 1990
  • K884915Dantec 22K60/61/62 Catheter Tip TransducerDantec Electronics, Inc. · 1989
  • K881915Dantec Magnetic StimulatorDantec Electronics, Inc. · 1988
  • K87475913L81 Disposable Sphincter Electrode, 13L33 CableDantec Electronics, Inc. · 1988

Recent decisions in FAP

The FAP category page

  • K113771Signal Gear Urethral Catheter ElectrodeNeurovision Medical Products, Inc. · 20122 recalls
  • K974775Single Channel Urological Pressure Gauge, Dual Channel Urological Pressure GaugeAirtronic Services, Inc. · 1998
  • K963330Urodynamic Analysis ModuleSynectics Medical, Inc. · 1997
  • K962472Rusch Urodynamic Rectal Balloon 2-Way CatheterRusch Intl. · 19961 recall
  • K931175Schuster Disposable Balloon ProbeSandhill Scientific, Inc. · 19942 recalls

https://510kreport.com/device/K874758 · printed Nov 4, 2026

Cite this page

510(k) Report. “K874758: Dantec 13L40 ST. Marks's Pudendal Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K874758

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026