Cleared Traditional

K790893 - STAT (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K790893 · Varian Assoc., Inc. · Ophthalmic device
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Aug 1979
Decision
112d
Days
Class 2
Risk

K790893 is an FDA 510(k) clearance for the STAT. Classified as Instrument, Vitreous Aspiration And Cutting, Battery-powered (product code HKP), Class II - Special Controls.

Submitted by Varian Assoc., Inc. (Mchenry, US). The FDA issued a Cleared decision on August 28, 1979 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4150 - 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 Varian Assoc., Inc. devices

Submission Details

510(k) Number K790893 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1979
Decision Date August 28, 1979
Days to Decision 112 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 110d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HKP Instrument, Vitreous Aspiration And Cutting, Battery-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4150
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.