Not Cleared Direct

DEN170021 - SEM Scanner (Model 200) (FDA 510(k) Clearance)

Class I Gastroenterology & Urology device.

DEN170021 · Bruin Biometrics, LLC · Gastroenterology & Urology device
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Dec 2018
Decision
626d
Days
Class 1
Risk

DEN170021 is an FDA 510(k) submission (not cleared) for the SEM Scanner (Model 200). Classified as Pressure Ulcer Management Tool (product code QEF), Class I - General Controls.

Submitted by Bruin Biometrics, LLC (Los Angeles, US). The FDA issued a Not Cleared (DENG) decision on December 20, 2018 after a review of 626 days.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.2100 - 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: Regulatory edge-case submission. High predicate equivalence gap. With 626 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

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Submission Details

510(k) Number DEN170021 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received April 03, 2017
Decision Date December 20, 2018
Days to Decision 626 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
496d slower than avg
Panel avg: 130d · This submission: 626d
Pathway characteristics

Device Classification

Product Code QEF Pressure Ulcer Management Tool
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.2100
Definition A Pressure Ulcer Management Tool Is A Prescription Device Intended For Patients At Risk Of Developing Pressure Ulcers. The Device Provides Output That Supports A User’s Decision To Increase Intervention. The Device Is An Adjunct Tool For Pressure Ulcer Management That Is Not Intended For Detection Or Diagnostic Purposes.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.