Cleared Traditional

K871046 - COMPASS STEREOTACTIC POSITIONING SYSTEM

K871046 is an FDA 510(k) clearance for COMPASS STEREOTACTIC POSITIONING SYSTEM, manufactured by Stereotactic Medical Systems, Inc.. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K871046 · Stereotactic Medical Systems, Inc. · Neurology device
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May 1987
Decision
52d
Days
Class 2
Risk

K871046 is an FDA 510(k) clearance for the COMPASS STEREOTACTIC POSITIONING SYSTEM. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Stereotactic Medical Systems, Inc. (New Harford, US). The FDA issued a Cleared decision on May 8, 1987 after a review of 52 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 Stereotactic Medical Systems, Inc. devices

FDA 510(k) Submission Details - K871046

510(k) Number K871046 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1987
Decision Date May 08, 1987
Days to Decision 52 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 148d · This submission: 52d
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 242
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K871046.
STEALTHSTATION
K954276 · Surgical Navigation Technologies, Inc. · Jan 1996
COOK STEREOTAXIC GUIDE
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TARGET PROGRAM & EPSON HX-20 COMPUTER
K872877 · Walter Lorenz Surgical, Inc. · Feb 1988
KOMAI CT-STEREOTACTIC APPARATUS AND ACCESSORIES
K861629 · Downs Surgical , Ltd. · Aug 1986
DIASONICS, BERGER STEREOTACTIC NEOROBIOPSY
K851973 · Diasonics, Inc. · Jul 1985
MENISCECTOMY TRAY #9715
K823424 · Concept, Inc. · Mar 1983