Not Cleared Post-NSE

DEN990005 - THE 3PM EGG MACHINE (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through the Post-NSE 510(k) pathway - typically does not require clinical trials.

DEN990005 · 3pm Co., Inc. · Gastroenterology & Urology device
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Aug 1999
Decision
39d
Days
Class 2
Risk

DEN990005 is an FDA 510(k) submission (not cleared) for the THE 3PM EGG MACHINE. Classified as System, Electrogastrography (egg) (product code MYE), Class II - Special Controls.

Submitted by 3pm Co., Inc. (Washington, US). The FDA issued a Not Cleared (DENG) decision on August 20, 1999 after a review of 39 days.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1735 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Gastroenterology & Urology review framework.

View all 3pm Co., Inc. devices

Submission Details

510(k) Number DEN990005 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received July 12, 1999
Decision Date August 20, 1999
Days to Decision 39 days
Submission Type Post-NSE
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 130d · This submission: 39d
Pathway characteristics

Device Classification

Product Code MYE System, Electrogastrography (egg)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1735
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.