Cleared Traditional

K842124 - EMG MODULE

K842124 is the FDA 510(k) clearance for EMG MODULE by Endotek Corp.. It is a Class 2 Gastroenterology & Urology device (product code FAP) cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K842124 · Endotek Corp. · Gastroenterology & Urology device
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Aug 1984
Decision
71d
Days
Class 2
Risk

K842124 is an FDA 510(k) clearance for the EMG MODULE, EMG1, W/OPTIONAL SPEAKER. Classified as Cystometric Gas (carbon-dioxide) On Hydraulic Device (product code FAP), Class II - Special Controls.

Submitted by Endotek Corp. (Walker, US). The FDA issued a Cleared decision on August 8, 1984 after a review of 71 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Endotek Corp. devices

Submission Details

510(k) Number K842124 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 1984
Decision Date August 08, 1984
Days to Decision 71 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
59d faster than avg
Panel avg: 130d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 23
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