Cleared Traditional

INFINITY MICRO IRRIGATOR (K924052) - FDA 510(k) Clearance

Class I Ophthalmic device.

K924052 · Infinity Surgical Technology, Inc. · Ophthalmic device
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Dec 1992
Decision
133d
Days
Class 1
Risk

K924052 is an FDA 510(k) clearance for the INFINITY MICRO IRRIGATOR. Classified as Device, Irrigation, Ocular Surgery (product code KYG), Class I - General Controls.

Submitted by Infinity Surgical Technology, Inc. (Northbrook, US). The FDA issued a Cleared decision on December 23, 1992 after a review of 133 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4360 - 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 Infinity Surgical Technology, Inc. devices

Submission Details

510(k) Number K924052 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1992
Decision Date December 23, 1992
Days to Decision 133 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
23d slower than avg
Panel avg: 110d · This submission: 133d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KYG Device, Irrigation, Ocular Surgery
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4360
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.