Cleared Traditional

K002893 - FLUOROLAB PLUS

K002893 is an FDA 510(k) clearance for FLUOROLAB PLUS, manufactured by Z-Kat, Inc.. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K002893 · Z-Kat, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2000
Decision
77d
Days
Class 2
Risk

K002893 is an FDA 510(k) clearance for the FLUOROLAB PLUS. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Z-Kat, Inc. (Hollywood, US). The FDA issued a Cleared decision on December 4, 2000 after a review of 77 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.

FDA 510(k) Submission Details - K002893

510(k) Number K002893 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2000
Decision Date December 04, 2000
Days to Decision 77 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
72d faster than avg
Panel avg: 149d · This submission: 77d
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 413
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K002893.
STRYKER REMOTE SURGICAL PLANNING SYSTEM
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K003111 · Stryker Instruments · Jan 2001
STEALTHSTATION TREATMENT GUIDANCE PLATFORM
K003201 · Medtronic Surgical Navigation Technologies · Dec 2000
STRYKER NAVIGATION SYSTEM - ENT MODULE
K002732 · Stryker Corp. · Oct 2000
INSIGHT IMAGE GUIDED SURGICAL SYSTEM
K001642 · Surgical Insights, Inc. · Sep 2000
NAVITRAK SYSTEM-OPTICAL OPTION, MODEL 900.004
K002053 · Orthosoft, Inc. · Aug 2000
K002893 · FLUOROLAB PLUS
Download PDF FDA Summary Z-Kat, Inc.