Cleared Traditional

KAMPPETER ANOMALOSCOPE (K930575) - FDA 510(k) Clearance

Class I Ophthalmic device.

K930575 · Bova Intl. · Ophthalmic device
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Feb 1994
Decision
386d
Days
Class 1
Risk

K930575 is an FDA 510(k) clearance for the KAMPPETER ANOMALOSCOPE. Classified as Anomaloscope (product code HIW), Class I - General Controls.

Submitted by Bova Intl. (Fort Worth, US). The FDA issued a Cleared decision on February 25, 1994 after a review of 386 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1070 - 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 Bova Intl. devices

Submission Details

510(k) Number K930575 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1993
Decision Date February 25, 1994
Days to Decision 386 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
276d slower than avg
Panel avg: 110d · This submission: 386d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HIW Anomaloscope
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1070
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.