Cleared Traditional

K843227 - MACULAR FUNCTION ANALYZER (FDA 510(k) Clearance)

Class I Ophthalmic device.

K843227 · Danek Medical, Inc. · Ophthalmic device
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Jul 1985
Decision
340d
Days
Class 1
Risk

K843227 is an FDA 510(k) clearance for the MACULAR FUNCTION ANALYZER. Classified as Grid, Amsler (product code HOQ), Class I - General Controls.

Submitted by Danek Medical, Inc. (Walker, US). The FDA issued a Cleared decision on July 22, 1985 after a review of 340 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1330 - 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. Elevated predicate reliance profile. 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 Danek Medical, Inc. devices

Submission Details

510(k) Number K843227 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1984
Decision Date July 22, 1985
Days to Decision 340 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
230d slower than avg
Panel avg: 110d · This submission: 340d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HOQ Grid, Amsler
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1330
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.