Cleared Traditional

GENERATED RETINAL REFLEX IMAGERY SYS (K840840) - FDA 510(k) Clearance

Class I Ophthalmic device.

K840840 · Electro Optical Instruments · Ophthalmic device
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Jul 1984
Decision
139d
Days
Class 1
Risk

K840840 is an FDA 510(k) clearance for the GENERATED RETINAL REFLEX IMAGERY SYS. Classified as Retinoscope, Battery-powered (product code HKM), Class I - General Controls.

Submitted by Electro Optical Instruments (Mchenry, US). The FDA issued a Cleared decision on July 12, 1984 after a review of 139 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1780 - 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 Electro Optical Instruments devices

Submission Details

510(k) Number K840840 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1984
Decision Date July 12, 1984
Days to Decision 139 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 110d · This submission: 139d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HKM Retinoscope, Battery-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1780
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.