Cleared Traditional

K031788 - PATHFINDER

K031788 is an FDA 510(k) clearance for PATHFINDER, manufactured by Massie Research Laboratories, Inc.. The device is a Class 2 Ophthalmic device with product code MXK cleared through the Traditional 510(k) pathway after a 450-day FDA review.

K031788 · Massie Research Laboratories, Inc. · Ophthalmic device
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Sep 2004
Decision
450d
Days
Class 2
Risk

K031788 is an FDA 510(k) clearance for the PATHFINDER. Classified as Device, Analysis, Anterior Segment (product code MXK), Class II - Special Controls.

Submitted by Massie Research Laboratories, Inc. (Pleasanton, US). The FDA issued a Cleared decision on September 2, 2004 after a review of 450 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1850 - the FDA ophthalmic 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 Ophthalmic submissions.

View all Massie Research Laboratories, Inc. devices

FDA 510(k) Submission Details - K031788

510(k) Number K031788 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2003
Decision Date September 02, 2004
Days to Decision 450 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
340d slower than avg
Panel avg: 110d · This submission: 450d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MXK Device Classification - Class 2, Special Controls

Product Code MXK Device, Analysis, Anterior Segment
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1850
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 Ophthalmic devices follow this clearance model.

Regulatory Peers - MXK Device, Analysis, Anterior Segment

All 11
Devices cleared under the same product code (MXK) and FDA review panel - the closest regulatory comparables to K031788.
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