Cleared Traditional

K964229 - REGULUS NAVIGATOR

K964229 is an FDA 510(k) clearance for REGULUS NAVIGATOR, manufactured by Compass Intl., Inc.. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 300-day FDA review.

K964229 · Compass Intl., Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1997
Decision
300d
Days
Class 2
Risk

K964229 is an FDA 510(k) clearance for the REGULUS NAVIGATOR. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Compass Intl., Inc. (Rochester, US). The FDA issued a Cleared decision on August 19, 1997 after a review of 300 days - an unusually long review period, suggesting complex equivalence evaluation.

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 Compass Intl., Inc. devices

FDA 510(k) Submission Details - K964229

510(k) Number K964229 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1996
Decision Date August 19, 1997
Days to Decision 300 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
152d slower than avg
Panel avg: 148d · This submission: 300d
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 332
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K964229.
STEALTHSTATION SYSTEM
K974161 · Surgical Navigation Technologies, Inc. · Nov 1997
CAROLINE GUIDE/DELIA LOCALIZER
K973277 · Surgical Solutions, Inc. · Nov 1997
STEALTHSTATION PASSIVE INSTRUMENT OPTION
K972398 · Surgical Navigation Technologies, Inc. · Sep 1997
SNT STEREOTACTIC LOCALIZATION SYSTEM
K971675 · Surgical Navigation Technologies, Inc. · Jul 1997
SNT DISPOSABLE BIOPSY NEEDLE
K971247 · Surgical Navigation Technologies, Inc. · Jun 1997
ISG FAMILY OF VIEWING WANDS
K970865 · I.S.G. Technologies, Inc. · Jun 1997