Cleared Traditional

SPHERZ (K022074) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K022074 · I.Z.I. Corp. · Neurology device
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Aug 2002
Decision
48d
Days
Class 2
Risk

K022074 is an FDA 510(k) clearance for the SPHERZ. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by I.Z.I. Corp. (Baltimore, US). The FDA issued a Cleared decision on August 13, 2002 after a review of 48 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 I.Z.I. Corp. devices

Submission Details

510(k) Number K022074 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2002
Decision Date August 13, 2002
Days to Decision 48 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 148d · This submission: 48d
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 105
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K022074.
SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR HIP APPLICATIONS
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K021815 · Smith & Nephew, Inc. · Oct 2002
SMITH & NEPHEW IMAGE GUIDED SURGICAL SYSTEM FOR KNEE APPLICATIONS
K022460 · Smith & Nephew, Inc. · Aug 2002
ORTHOPILOT HTO MODULE
K021327 · Aesculap, Inc. · Jul 2002
ENDOMAP
K014113 · Siemens Medical Solutions USA, Inc. · Jun 2002
ORTHOPILOT 2
K013569 · Aesculap, Inc. · Apr 2002