Cleared Traditional

K834145 - ERGO DIAGNOSTIC CARD

K834145 is an FDA 510(k) clearance for ERGO DIAGNOSTIC CARD, manufactured by American Ergo Systems. The device is a Class 1 Ophthalmic device with product code HOX cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K834145 · American Ergo Systems · Ophthalmic device
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Mar 1984
Decision
106d
Days
Class 1
Risk

K834145 is an FDA 510(k) clearance for the ERGO DIAGNOSTIC CARD. Classified as Chart, Visual Acuity (product code HOX), Class I - General Controls.

Submitted by American Ergo Systems (Mchenry, US). The FDA issued a Cleared decision on March 16, 1984 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1150 - 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 American Ergo Systems devices

FDA 510(k) Submission Details - K834145

510(k) Number K834145 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1983
Decision Date March 16, 1984
Days to Decision 106 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 110d · This submission: 106d
Pathway characteristics
Predicate-based equivalence.

HOX Device Classification - Class 1, General Controls

Product Code HOX Chart, Visual Acuity
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1150
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 - HOX Chart, Visual Acuity

All 9
Devices cleared under the same product code (HOX) and FDA review panel - the closest regulatory comparables to K834145.
MENTOR B-VAT(TM) II VIDEO TESTER
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CANON AUTO ACUITOMETER CV-10
K861416 · Canon USA, Inc. · May 1986
MENTOR BRIGHTNESS ACUITY TESTER
K853736 · Mentor O & O, Inc. · Nov 1985
VFS 1000/SCREENING FUNCTION ANALYZER
K830011 · CooperVision, Inc. · Jan 1983
NIC OPTRONICS CS-2000
K822215 · Nicolet Biomedical Instruments · Aug 1982
MENTOR POTENTIAL ACUITY METER
K821932 · Mentor O & O, Inc. · Aug 1982