Cleared Traditional

MTI PHOTOSCREENER (K934880) - FDA 510(k) Clearance

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K934880 · Medical Technology and Innovations, Inc. · Ophthalmic device
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Apr 1994
Decision
176d
Days
Class 2
Risk

K934880 is an FDA 510(k) clearance for the MTI PHOTOSCREENER. Classified as Photorefractor (product code MMF), Class II - Special Controls.

Submitted by Medical Technology and Innovations, Inc. (Cedar Falls, US). The FDA issued a Cleared decision on April 6, 1994 after a review of 176 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1120 - 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 Medical Technology and Innovations, Inc. devices

Submission Details

510(k) Number K934880 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 1993
Decision Date April 06, 1994
Days to Decision 176 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d slower than avg
Panel avg: 110d · This submission: 176d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MMF Photorefractor
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1120
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.