Cleared Traditional

K890598 - MOLTENO IMPLANT

K890598 is an FDA 510(k) clearance for MOLTENO IMPLANT, manufactured by Iop, Inc.. The device is a Class 2 Ophthalmic device with product code KYF cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K890598 · Iop, Inc. · Ophthalmic device

Download Printable Device Report (PDF)

Optimized for regulatory review, auditing and printing

Feb 1989

Decision

21d

Days

Class 2

Risk

K890598 is an FDA 510(k) clearance for the MOLTENO IMPLANT. 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 February 27, 1989 after a review of 21 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K890598

510(k) Number	K890598 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 06, 1989
Decision Date	February 27, 1989
Days to Decision	21 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	-
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

89d faster than avg

Panel avg: 110d · This submission: 21d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

KYF Device Classification - Class 2, Special Controls

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 K890598.

BAERVELDT GLAUCOMA IMPLANT

K905129 · Wright Medical Corp. · Feb 1991

OPTIMED GLAUCOMA PRESSURE REGULATOR

K903462 · Optimed, Inc. · Oct 1990

MODIFIED MOLTENO(TM) IMPLANTS

K902489 · Iop, Inc. · Aug 1990

KRUPIN EYE VALVE W/SCLERAL BUCKLE

K885125 · Hood Laboratories · Jan 1989

MOLTENO VALVE SETON

K875099 · Staar Surgical Co. · Mar 1988

WHITE OCULAR PRESSURE RELIEF DEVICE

K840204 · Precision-Cosmet Co., Inc. · Feb 1985

FDA 510(k) Resources - Ophthalmic

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K890598

Iop, Inc.

Malibu, CA · US

JASON MALECKA

Regulatory profile

9 submissions 8 cleared

89% clearance rate · Active in Ophthalmic

View all devices by Iop, Inc. →

About This 510(k) Record

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . FDA decision: February 27, 1989. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: October 2026.

Verify on FDA.gov

510k Database

510(k) clearances indexed 176,583

Regulatory data since 1976

FDA monthly sync November 6, 2026