Cleared Traditional

K053164 - IPLAN FLOW

K053164 is the FDA 510(k) clearance for IPLAN FLOW by Brainlab AG. It is a Class 2 Neurology device (product code HAW) cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K053164 · Brainlab AG · Neurology device
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Mar 2006
Decision
129d
Days
Class 2
Risk

K053164 is an FDA 510(k) clearance for the IPLAN FLOW. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Brainlab AG (Heimstetten, DE). The FDA issued a Cleared decision on March 23, 2006 after a review of 129 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4560 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Brainlab AG devices

Submission Details

510(k) Number K053164 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2005
Decision Date March 23, 2006
Days to Decision 129 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
19d faster than avg
Panel avg: 148d · This submission: 129d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HAW Neurological Stereotaxic Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
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 - HAW Neurological Stereotaxic Instrument

All 217
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K053164.
BRIGIT SURGICAL DEVICE
K060556 · Zimmer, Inc. · Jul 2006
BRAINPRO, BRAINPRO ACCESS
K060808 · PAJUNK GmbH Medizintechnologie · Jul 2006
VECTORVISION SPINE
K053159 · Brainlab AG · Jun 2006
BIOMET PRE-CALIBRATED COMPUTER AIDED SURGERY NAVIGATION INSTRUMENTS FOR HIP APPLICATIONS
K060121 · Biomet Manufacturing Corp · Mar 2006
VECTORVISION HIP
K060468 · Brainlab AG · Mar 2006
IMAGELESS HIP MODULE FOR THE STEALTHSTATION SYSTEM
K052623 · Medtronic Navigation, Inc. · Mar 2006