Cleared Traditional

K042391 - KOLIBRI IMAGE GUIDED SURGERY SYSTEM

K042391 is an FDA 510(k) clearance for KOLIBRI IMAGE GUIDED SURGERY SYSTEM, manufactured by Brainlab AG. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K042391 · Brainlab AG · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2004
Decision
47d
Days
Class 2
Risk

K042391 is an FDA 510(k) clearance for the KOLIBRI IMAGE GUIDED SURGERY SYSTEM. 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 October 19, 2004 after a review of 47 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Brainlab AG devices

FDA 510(k) Submission Details - K042391

510(k) Number K042391 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 2004
Decision Date October 19, 2004
Days to Decision 47 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
101d faster than avg
Panel avg: 148d · This submission: 47d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HAW Device Classification - Class 2, Special Controls

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 258
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K042391.
NAVIGUS NEXDRIVE, MODEL MI-3000
K043091 · Image-Guided Neurologics, Inc. · Feb 2005
VECTORVISION ACL
K042512 · Brainlab AG · Jan 2005
IPLAN!
K041703 · Brainlab AG · Oct 2004
VECTORVISION UNI-KNEE
K041899 · Brainlab AG · Oct 2004
NAVIGUS PASSIVE PROBE, MODEL NP-1000
K040334 · Image-Guided Neurologics, Inc. · Oct 2004
IPLAN! FLOW
K041330 · Brainlab AG · Sep 2004