Cleared Traditional

K841861 - CANON AUTOREF R-10

K841861 is an FDA 510(k) clearance for CANON AUTOREF R-10, manufactured by Canon USA, Inc.. The device is a Class 1 Ophthalmic device with product code HKO cleared through the Traditional 510(k) pathway after a 154-day FDA review.

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

FDA 510(k) Submission Details - K841861

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d slower than avg
Panel avg: 110d · This submission: 154d
Pathway characteristics
Predicate-based equivalence.

HKO Device Classification - Class 1, General Controls

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.

Regulatory Peers - HKO Refractometer, Ophthalmic

All 20
Devices cleared under the same product code (HKO) and FDA review panel - the closest regulatory comparables to K841861.
AR-1100 AUTOMATIC REFRACTOR
K861065 · Nidek, Inc. · Apr 1986
AR-1600 AUTOMATIC REFRACTOR
K861062 · Nidek, Inc. · Apr 1986
AR-1000 AUTOMATIC REFRACTOR
K861066 · Nidek, Inc. · Apr 1986
AUTO REFRACTOMETER
K831083 · Nidek, Inc. · Jun 1983
I.V.E. REFRACTION SYSTEM
K812896 · Bausch & Lomb, Inc. · Dec 1981
SR-1V DATA PRINTER
K812063 · American Optical Corp. · Aug 1981