Not Cleared Direct

DEN200042 - BrainTemp Neonate System (BTNeo System) (FDA 510(k) Clearance)

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

DEN200042 · Brain Temp, Inc. · Neurology device
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Mar 2022
Decision
644d
Days
Class 2
Risk

DEN200042 is an FDA 510(k) submission (not cleared) for the BrainTemp Neonate System (BTNeo System). Classified as Brain Temperature Measurement System (product code QSL), Class II - Special Controls.

Submitted by Brain Temp, Inc. (Bryn Mawr, US). The FDA issued a Not Cleared (DENG) decision on March 29, 2022 after a review of 644 days.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1565 - the FDA neurology 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 644 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 Brain Temp, Inc. devices

Submission Details

510(k) Number DEN200042 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received June 23, 2020
Decision Date March 29, 2022
Days to Decision 644 days
Submission Type Direct
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
496d slower than avg
Panel avg: 148d · This submission: 644d
Pathway characteristics

Device Classification

Product Code QSL Brain Temperature Measurement System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1565
Definition A Brain Temperature Measurement System Is An Externally Placed, Prescription Device Intended To Measure Brain Temperature.
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 Neurology devices follow this clearance model.