Cleared Traditional

KARICKHOFF FLYING CORPUSCLE VIEWER (K831829) - FDA 510(k) Clearance

Class I Ophthalmic device.

K831829 · Surgidev Corp. · Ophthalmic device
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Oct 1983
Decision
134d
Days
Class 1
Risk

K831829 is an FDA 510(k) clearance for the KARICKHOFF FLYING CORPUSCLE VIEWER. Classified as Maxwell Spot, Ac-powered (product code HIX), Class I - General Controls.

Submitted by Surgidev Corp. (Walker, US). The FDA issued a Cleared decision on October 19, 1983 after a review of 134 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1435 - 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 Surgidev Corp. devices

Submission Details

510(k) Number K831829 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 1983
Decision Date October 19, 1983
Days to Decision 134 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d slower than avg
Panel avg: 110d · This submission: 134d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HIX Maxwell Spot, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1435
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.