Cleared Traditional

K022304 - ACCUMAP AUTOMATIC PERIMETER

K022304 is an FDA 510(k) clearance for ACCUMAP AUTOMATIC PERIMETER, manufactured by Objectivision Pty , Ltd.. The device is a Class 2 Neurology device with product code GWE cleared through the Traditional 510(k) pathway after a 486-day FDA review.

K022304 · Objectivision Pty , Ltd. · Neurology device
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Nov 2003
Decision
486d
Days
Class 2
Risk

K022304 is an FDA 510(k) clearance for the ACCUMAP AUTOMATIC PERIMETER. Classified as Stimulator, Photic, Evoked Response (product code GWE), Class II - Special Controls.

Submitted by Objectivision Pty , Ltd. (Troy, US). The FDA issued a Cleared decision on November 14, 2003 after a review of 486 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1890 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Objectivision Pty , Ltd. devices

FDA 510(k) Submission Details - K022304

510(k) Number K022304 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2002
Decision Date November 14, 2003
Days to Decision 486 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
338d slower than avg
Panel avg: 148d · This submission: 486d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWE Device Classification - Class 2, Special Controls

Product Code GWE Stimulator, Photic, Evoked Response
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1890
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 - GWE Stimulator, Photic, Evoked Response

All 26
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