Cleared Traditional

K031831 - TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM

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

K031831 · Topcon Medical Systems, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K031831

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d slower than avg
Panel avg: 110d · This submission: 189d
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 K031831.
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K031831 · TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM
Download PDF FDA Summary Topcon Medical System…