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
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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.

View all Iop, Inc. devices

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
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 14
Devices cleared under the same product code (KYF) and FDA review panel - the closest regulatory comparables to K890598.
AHMED GLAUCOMA VALVE, MODEL S3
K980657 · New World Medical, Inc. · Apr 1998
BAERVELT PARS PLANA GLAUCOMA IMPLANT
K955455 · Pharmacia Iovision, Inc. · Feb 1997
KRUPIN EYE VALVE WITH DISK
K905703 · Hood Laboratories · Mar 1991
KRUPIN EYE VALVE W/SCLERAL BUCKLE
K885125 · Hood Laboratories · Jan 1989
MOLTENO VALVE SETON
K875099 · Staar Surgical Co. · Mar 1988