Cleared Traditional

BcSs-PICNI-2000 Sensor (K182073) - 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
Combination Product No
PCCP Authorized No
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 Consultant

Msquared Associates, Inc.
Connie Qiu

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GWM Device, Monitoring, Intracranial Pressure

All 28
Devices cleared under the same product code (GWM) and FDA review panel - the closest regulatory comparables to K182073.
Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser Level
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Becker External Drainage and Monitoring System
K200456 · Medtronic, Inc. · Mar 2020
CereLink ICP Monitor, CereLink ICP Extension Cable
K183406 · Integra Lifesciences Corp. · Jan 2019
AURA ICP MONITORING SYSTEM
K172209 · Branchpoint Technologies, Inc. · May 2018
CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter Kit
K173192 · Codman & Shurtleff, Inc. · Nov 2017