Cleared Traditional

TECHNA VISION AUTO-PERIMETER (K853290) - FDA 510(k) Clearance

Class I Ophthalmic device.

K853290 · Techna Vision · Ophthalmic device
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Nov 1985
Decision
99d
Days
Class 1
Risk

K853290 is an FDA 510(k) clearance for the TECHNA VISION AUTO-PERIMETER. Classified as Perimeter, Automatic, Ac-powered (product code HPT), Class I - General Controls.

Submitted by Techna Vision (Santee, US). The FDA issued a Cleared decision on November 12, 1985 after a review of 99 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1605 - 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.

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Submission Details

510(k) Number K853290 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1985
Decision Date November 12, 1985
Days to Decision 99 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 110d · This submission: 99d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HPT Perimeter, Automatic, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1605
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.