Cleared Traditional

K182073 - BcSs-PICNI-2000 Sensor (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K182073 · Braincare Desenvolvimento E Inovacao Tecnologica S.A. · Neurology device
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Oct 2019
Decision
442d
Days
Class 2
Risk

K182073 is an FDA 510(k) clearance for the BcSs-PICNI-2000 Sensor. Classified as Device, Monitoring, Intracranial Pressure (product code GWM), Class II - Special Controls.

Submitted by Braincare Desenvolvimento E Inovacao Tecnologica S.A. (Sao Carlos, BR). The FDA issued a Cleared decision on October 17, 2019 after a review of 442 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1620 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Braincare Desenvolvimento E Inovacao Tecnologica S.A. devices

Submission Details

510(k) Number K182073 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2018
Decision Date October 17, 2019
Days to Decision 442 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
294d slower than avg
Panel avg: 148d · This submission: 442d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GWM Device, Monitoring, Intracranial Pressure
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1620
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.

Regulatory Peers - GWM Device, Monitoring, Intracranial Pressure

All 104
Devices cleared under the same product code (GWM) and FDA review panel - the closest regulatory comparables to K182073.
Pressio 3 Multi-parameter Neuromonitoring System
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NEUROVENT-P (092946-003)
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K240821 · Braincare Desenvolvimento E Inova??o Tecnol?gica S.A. · Jul 2024
CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)
K232890 · Integra Lifesciences Production Corporation · Feb 2024
B4C System
K201989 · Braincare Desenvolvimento E Inovacao Tecnologica S.A. · Oct 2021
CereLink ICP Monitor
K210993 · Integra Lifesciences Production Corporation · Apr 2021