Cleared Traditional

K031831 - TOPCON MODEL BV-1000 AUTOMATED SUBJECTI...

K031831 is the FDA 510(k) clearance for TOPCON MODEL BV-1000 AUTOMATED SUBJECTI... by Topcon Medical Systems, Inc.. It is a Class 1 Ophthalmic device (product code HKO) cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K031831 · Topcon Medical Systems, Inc. · Ophthalmic device
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Dec 2003
Decision
189d
Days
Class 1
Risk

K031831 is an FDA 510(k) clearance for the TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM. Classified as Refractometer, Ophthalmic (product code HKO), Class I - General Controls.

Submitted by Topcon Medical Systems, Inc. (Paramus, US). The FDA issued a Cleared decision on December 19, 2003 after a review of 189 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 Topcon Medical Systems, Inc. devices

Submission Details

510(k) Number K031831 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 2003
Decision Date December 19, 2003
Days to Decision 189 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
79d slower than avg
Panel avg: 110d · This submission: 189d
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 15
Devices cleared under the same product code (HKO) and FDA review panel - the closest regulatory comparables to K031831.
AUTO REFF-30
K940516 · Canon, Inc. · Jul 1994
AUTOREF LENSMETER RL-10
K925304 · Canon USA, Inc. · Feb 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