Not Cleared Direct

DEN220065 - Pill Sense System (FDA 510(k) Clearance)

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

DEN220065 · Enterasense , Ltd. · Gastroenterology & Urology device
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Feb 2023
Decision
148d
Days
Class 2
Risk

DEN220065 is an FDA 510(k) submission (not cleared) for the Pill Sense System. Classified as Blood Detection Capsule (product code QUD), Class II - Special Controls.

Submitted by Enterasense , Ltd. (Galway, IE). The FDA issued a Not Cleared (DENG) decision on February 24, 2023 after a review of 148 days.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1390 - 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 Enterasense , Ltd. devices

Submission Details

510(k) Number DEN220065 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received September 29, 2022
Decision Date February 24, 2023
Days to Decision 148 days
Submission Type Direct
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 130d · This submission: 148d
Pathway characteristics

Device Classification

Product Code QUD Blood Detection Capsule
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1390
Definition Ingestible Gastrointestinal Blood Detection Capsule Device Is A Prescription Device That Uses Spectrophotometry (light Absorption Technology) To Detect The Presence Or Absence Of Blood In The Gastrointestinal Tract.
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.