Not Cleared Direct

DEN170072 - Enlight 1810 (FDA 510(k) Clearance)

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

DEN170072 · Timpel, Inc. · Anesthesiology device
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Dec 2018
Decision
447d
Days
Class 2
Risk

DEN170072 is an FDA 510(k) submission (not cleared) for the Enlight 1810. Classified as Ventilatory Electrical Impedance Tomograph (product code QEB), Class II - Special Controls.

Submitted by Timpel, Inc. (Sao Paulo-Sp, BR). The FDA issued a Not Cleared (DENG) decision on December 20, 2018 after a review of 447 days.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1505 - the FDA anesthesiology and respiratory 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 447 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.

View all Timpel, Inc. devices

Submission Details

510(k) Number DEN170072 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received September 29, 2017
Decision Date December 20, 2018
Days to Decision 447 days
Submission Type Direct
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
308d slower than avg
Panel avg: 139d · This submission: 447d
Pathway characteristics

Device Classification

Product Code QEB Ventilatory Electrical Impedance Tomograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1505
Definition A Ventilatory Electrical Impedance Tomograph Is A Prescription Non-invasive, Non-radiological Ventilatory Device That Provides An Assessment Of Local Impedance Variation Within A Cross-section Of A Patient’s Thorax.
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 Anesthesiology devices follow this clearance model.