Cleared Traditional

MODIFIED MOLTENO(TM) IMPLANTS (K902489) - FDA 510(k) Clearance

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

K902489 · Iop, Inc. · Ophthalmic device
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Aug 1990
Decision
90d
Days
Class 2
Risk

K902489 is an FDA 510(k) clearance for the MODIFIED MOLTENO(TM) IMPLANTS. Classified as Implant, Eye Valve (product code KYF), Class II - Special Controls.

Submitted by Iop, Inc. (Malibu, US). The FDA issued a Cleared decision on August 14, 1990 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.3920 - 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 Iop, Inc. devices

Submission Details

510(k) Number K902489 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1990
Decision Date August 14, 1990
Days to Decision 90 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 110d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KYF Implant, Eye Valve
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.3920
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.

Regulatory Peers - KYF Implant, Eye Valve

All 24
Devices cleared under the same product code (KYF) and FDA review panel - the closest regulatory comparables to K902489.
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K182518 · New World Medical, Inc. · Jan 2019