Cleared Traditional

PRIZM KERATOME BLADE, MODEL MK8512M2 (K033236) - FDA 510(k) Clearance

Class I Ophthalmic device.

K033236 · Surgin Surgical Instrumentation, Inc. · Ophthalmic device
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Mar 2004
Decision
172d
Days
Class 1
Risk

K033236 is an FDA 510(k) clearance for the PRIZM KERATOME BLADE, MODEL MK8512M2. Classified as Keratome, Ac-powered (product code HNO), Class I - General Controls.

Submitted by Surgin Surgical Instrumentation, Inc. (Tustin, US). The FDA issued a Cleared decision on March 26, 2004 after a review of 172 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4370 - 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 Surgin Surgical Instrumentation, Inc. devices

Submission Details

510(k) Number K033236 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 2003
Decision Date March 26, 2004
Days to Decision 172 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
62d slower than avg
Panel avg: 110d · This submission: 172d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HNO Keratome, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4370
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.