Cleared Traditional

K925304 - AUTOREF LENSMETER RL-10

K925304 is the FDA 510(k) clearance for AUTOREF LENSMETER RL-10 by Canon USA, Inc.. It is a Class 1 Ophthalmic device (product code HKO) cleared through the Traditional 510(k) pathway after a 484-day FDA review.

K925304 · Canon USA, Inc. · Ophthalmic device
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Feb 1994
Decision
484d
Days
Class 1
Risk

K925304 is an FDA 510(k) clearance for the AUTOREF LENSMETER RL-10. Classified as Refractometer, Ophthalmic (product code HKO), Class I - General Controls.

Submitted by Canon USA, Inc. (Tokyo 146, JP). The FDA issued a Cleared decision on February 17, 1994 after a review of 484 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Ophthalmic submissions.

View all Canon USA, Inc. devices

Submission Details

510(k) Number K925304 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1992
Decision Date February 17, 1994
Days to Decision 484 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
374d slower than avg
Panel avg: 110d · This submission: 484d
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.

Regulatory Peers - HKO Refractometer, Ophthalmic

All 18
Devices cleared under the same product code (HKO) and FDA review panel - the closest regulatory comparables to K925304.
AUTO REFF-30
K940516 · Canon, Inc. · Jul 1994
AR-1600G AUTO-REFRACTOMETER
K902500 · Nidek, Inc. · Jul 1990
NIDEK RT-1200S (MARCO TRS-1200)
K901513 · Nidek, Inc. · Jun 1990
NIDEK AR-1200
K890559 · Nidek, Inc. · Feb 1989
CANON AUTOREFRACTOMETER R-22
K883200 · Canon USA, Inc. · Aug 1988
NIDEK ARK-2000
K882191 · Nidek, Inc. · Jul 1988