Cleared Traditional

K802183 - SR-IV PROGRAMMED SUBJECTIVE REFRACTOR (FDA 510(k) Clearance)

Class I Ophthalmic device.

K802183 · American Optical Corp. · Ophthalmic device
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Apr 1981
Decision
226d
Days
Class 1
Risk

K802183 is an FDA 510(k) clearance for the SR-IV PROGRAMMED SUBJECTIVE REFRACTOR. Classified as Refractometer, Ophthalmic (product code HKO), Class I - General Controls.

Submitted by American Optical Corp. (Mchenry, US). The FDA issued a Cleared decision on April 23, 1981 after a review of 226 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 American Optical Corp. devices

Submission Details

510(k) Number K802183 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1980
Decision Date April 23, 1981
Days to Decision 226 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
116d slower than avg
Panel avg: 110d · This submission: 226d
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.