Cleared Traditional

K920937 - COMPUTERIZED PUPIL (FDA 510(k) Clearance)

Class I Ophthalmic device.

K920937 · Trek Medical Products, Inc. · Ophthalmic device
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Oct 1992
Decision
218d
Days
Class 1
Risk

K920937 is an FDA 510(k) clearance for the COMPUTERIZED PUPIL. Classified as Pupillometer, Ac-powered (product code HLG), Class I - General Controls.

Submitted by Trek Medical Products, Inc. (Muckwonago, US). The FDA issued a Cleared decision on October 2, 1992 after a review of 218 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1700 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Trek Medical Products, Inc. devices

Submission Details

510(k) Number K920937 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1992
Decision Date October 02, 1992
Days to Decision 218 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
108d slower than avg
Panel avg: 110d · This submission: 218d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HLG Pupillometer, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1700
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.