Cleared Traditional

K942242 - AUTO REF-KERATOMETER, RK-3

K942242 is an FDA 510(k) clearance for AUTO REF-KERATOMETER, manufactured by Cannon U.S.A., Inc.. The device is a Class 1 Ophthalmic device with product code HKO cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K942242 · Cannon U.S.A., Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 1994
Decision
116d
Days
Class 1
Risk

K942242 is an FDA 510(k) clearance for the AUTO REF-KERATOMETER, RK-3. Classified as Refractometer, Ophthalmic (product code HKO), Class I - General Controls.

Submitted by Cannon U.S.A., Inc. (Lake Success, US). The FDA issued a Cleared decision on September 2, 1994 after a review of 116 days - within the typical 510(k) review window.

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 - K942242

510(k) Number K942242 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1994
Decision Date September 02, 1994
Days to Decision 116 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 110d · This submission: 116d
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 31
Devices cleared under the same product code (HKO) and FDA review panel - the closest regulatory comparables to K942242.
WAVESCAN WAVEFRONT SYSTEM MODEL HS 1
K000327 · Visx, Incorporated · May 2000
DIGITAL RETINOSCOPIC PHOTOMETER
K951179 · Kudi Kalu, Inc. · May 1995
VIDEO VISION ANALYZER (VIVA), VRB 100
K945959 · Tomey Corporation USA · Mar 1995
AUTO REFF-30
K940516 · Canon, Inc. · Jul 1994
AUTOREF LENSMETER RL-10
K925304 · Canon USA, Inc. · Feb 1994
OPTEC 3000
K924741 · Stereo Optical Co., Inc. · Apr 1993
K942242 · AUTO REF-KERATOMETER, RK-3
Download PDF FDA Summary Cannon U.S.A., Inc.