Cleared Traditional

K934880 - MTI PHOTOSCREENER

K934880 is an FDA 510(k) clearance for MTI PHOTOSCREENER, manufactured by Medical Technology and Innovations, Inc.. The device is a Class 2 Ophthalmic device with product code MMF cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K934880 · Medical Technology and Innovations, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
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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

FDA 510(k) Submission Details - K934880

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.

MMF Device Classification - Class 2, Special Controls

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.