Cleared Traditional

K092192 - WAYPOINT STEREOTACTIC SYSTEM

K092192 is an FDA 510(k) clearance for WAYPOINT STEREOTACTIC SYSTEM, manufactured by FHC, Inc.. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 206-day FDA review.

K092192 · FHC, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2010
Decision
206d
Days
Class 2
Risk

K092192 is an FDA 510(k) clearance for the WAYPOINT STEREOTACTIC SYSTEM. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by FHC, Inc. (Bowdoin, US). The FDA issued a Cleared decision on February 12, 2010 after a review of 206 days - an extended review 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: 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 FHC, Inc. devices

FDA 510(k) Submission Details - K092192

510(k) Number K092192 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2009
Decision Date February 12, 2010
Days to Decision 206 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
58d slower than avg
Panel avg: 148d · This submission: 206d
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 243
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K092192.
DISPOSABLE REFLECTIVE MARKER SPHERES
K100038 · Brainlab AG · Jul 2010
VECTORVISION CRANIAL, VECTORVISION ENT, KOLIBRI CRANIAL, KOLIBRI ENT, CRANIAL ESSENTIAL, CRANIAL UNLIMITED
K092467 · Brainlab AG · May 2010
IMNS MEDACTA NAVIGATION SYSTEM,33.221000US
K100314 · Medacta International S.A. · Mar 2010
CRANIAL IMAGE GUIDED SURGERY SYSTEM
K082060 · Brainlab AG · May 2009
LEKSELL STEREOTACTIC SYSTEM WITH REUSABLE FIXATION SCREWS
K080355 · Elekta Instrument AB · May 2009
PIGALILEO TOTAL HIP REPLACEMENT (THR) SOFTWARE APPLICATION V3.0
K083565 · Smith & Nephew, Inc. · Feb 2009