Cleared Traditional

K874759 - 13L81 DISPOSABLE SPHINCTER ELECTRODE, 13L33 CABLE

K874759 is an FDA 510(k) clearance for 13L81 DISPOSABLE SPHINCTER ELECTRODE, manufactured by Dantec Electronics, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FAP cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K874759 · Dantec Electronics, Inc. · Gastroenterology & Urology device
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Apr 1988
Decision
148d
Days
Class 2
Risk

K874759 is an FDA 510(k) clearance for the 13L81 DISPOSABLE SPHINCTER ELECTRODE, 13L33 CABLE. Classified as Cystometric Gas (carbon-dioxide) On Hydraulic Device (product code FAP), Class II - Special Controls.

Submitted by Dantec Electronics, Inc. (Allendale, US). The FDA issued a Cleared decision on April 14, 1988 after a review of 148 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1620 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Dantec Electronics, Inc. devices

FDA 510(k) Submission Details - K874759

510(k) Number K874759 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1987
Decision Date April 14, 1988
Days to Decision 148 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 131d · This submission: 148d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FAP Device Classification - Class 2, Special Controls

Product Code FAP Cystometric Gas (carbon-dioxide) On Hydraulic Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1620
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FAP Cystometric Gas (carbon-dioxide) On Hydraulic Device

All 40
Devices cleared under the same product code (FAP) and FDA review panel - the closest regulatory comparables to K874759.
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