Cleared Traditional

K930575 - KAMPPETER ANOMALOSCOPE

K930575 is an FDA 510(k) clearance for KAMPPETER ANOMALOSCOPE, manufactured by Bova Intl.. The device is a Class 1 Ophthalmic device with product code HIW cleared through the Traditional 510(k) pathway after a 386-day FDA review.

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

FDA 510(k) Submission Details - K930575

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.

HIW Device Classification - Class 1, General Controls

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.