Cleared Traditional

K841861 - CANON AUTOREF R-10 (FDA 510(k) Clearance)

Class I Ophthalmic device.

K841861 · Canon USA, Inc. · Ophthalmic device
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Oct 1984
Decision
154d
Days
Class 1
Risk

K841861 is an FDA 510(k) clearance for the CANON AUTOREF R-10. Classified as Refractometer, Ophthalmic (product code HKO), Class I - General Controls.

Submitted by Canon USA, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 5, 1984 after a review of 154 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1760 - 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 Canon USA, Inc. devices

Submission Details

510(k) Number K841861 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1984
Decision Date October 05, 1984
Days to Decision 154 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d slower than avg
Panel avg: 110d · This submission: 154d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HKO Refractometer, Ophthalmic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1760
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.