Cleared Traditional

K940516 - AUTO REFF-30

K940516 is an FDA 510(k) clearance for AUTO REFF-30, manufactured by Canon, Inc.. The device is a Class 1 Ophthalmic device with product code HKO cleared through the Traditional 510(k) pathway after a 158-day FDA review.

K940516 · Canon, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 1994
Decision
158d
Days
Class 1
Risk

K940516 is an FDA 510(k) clearance for the AUTO REFF-30. Classified as Refractometer, Ophthalmic (product code HKO), Class I - General Controls.

Submitted by Canon, Inc. (Ohta-Ku, Tokyo, Japan, JP). The FDA issued a Cleared decision on July 12, 1994 after a review of 158 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.

FDA 510(k) Submission Details - K940516

510(k) Number K940516 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1994
Decision Date July 12, 1994
Days to Decision 158 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
48d slower than avg
Panel avg: 110d · This submission: 158d
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 34
Devices cleared under the same product code (HKO) and FDA review panel - the closest regulatory comparables to K940516.
DIGITAL RETINOSCOPIC PHOTOMETER
K951179 · Kudi Kalu, Inc. · May 1995
VIDEO VISION ANALYZER (VIVA), VRB 100
K945959 · Tomey Corporation USA · Mar 1995
AUTO REF-KERATOMETER, RK-3
K942242 · Cannon U.S.A., Inc. · Sep 1994
AUTOREF LENSMETER RL-10
K925304 · Canon USA, Inc. · Feb 1994
OPTEC 3000
K924741 · Stereo Optical Co., Inc. · Apr 1993
BURTON AUTO REFRACTOR/KERATOMETER - MODEL BARK-8
K924778 · R.H. Burton Co. · Apr 1993
K940516 · AUTO REFF-30
Download PDF FDA Summary Canon, Inc.