Cleared Traditional

K920937 - COMPUTERIZED PUPIL

K920937 is an FDA 510(k) clearance for COMPUTERIZED PUPIL, manufactured by Trek Medical Products, Inc.. The device is a Class 1 Ophthalmic device with product code HLG cleared through the Traditional 510(k) pathway after a 218-day FDA review.

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

FDA 510(k) Submission Details - K920937

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.

HLG Device Classification - Class 1, General Controls

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.