Cleared Traditional

IM COLLAGEN SHIELD (K896449) - FDA 510(k) Clearance

Class I Ophthalmic device.

K896449 · Intermedical, Inc. · Ophthalmic device
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May 1990
Decision
196d
Days
Class 1
Risk

K896449 is an FDA 510(k) clearance for the IM COLLAGEN SHIELD. Classified as Collagen Corneal Shield (product code MOE), Class I - General Controls.

Submitted by Intermedical, Inc. (Safety Harbor, US). The FDA issued a Cleared decision on May 24, 1990 after a review of 196 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4750 - 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 Intermedical, Inc. devices

Submission Details

510(k) Number K896449 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1989
Decision Date May 24, 1990
Days to Decision 196 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d slower than avg
Panel avg: 110d · This submission: 196d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MOE Collagen Corneal Shield
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4750
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.