Cleared Traditional

K936205 - COMPREHENSIVE PHOROPTER, MDR-680 (FDA 510(k) Clearance)

Class I Ophthalmic device.

K936205 · Canon USA, Inc. · Ophthalmic device
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Sep 1994
Decision
273d
Days
Class 1
Risk

K936205 is an FDA 510(k) clearance for the COMPREHENSIVE PHOROPTER, MDR-680. Classified as Refractor, Manual, Non-powered, Including Phoropter (product code HKN), Class I - General Controls.

Submitted by Canon USA, Inc. (Lake Success, US). The FDA issued a Cleared decision on September 28, 1994 after a review of 273 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1770 - 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.

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Submission Details

510(k) Number K936205 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1993
Decision Date September 28, 1994
Days to Decision 273 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
163d slower than avg
Panel avg: 110d · This submission: 273d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HKN Refractor, Manual, Non-powered, Including Phoropter
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1770
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.