Cleared Traditional

K152996 - Molteno3 Glaucoma Implant

K152996 is an FDA 510(k) clearance for Molteno3 Glaucoma Implant, manufactured by Innovative Ophthalmic Products, Inc. (Iop). The device is a Class 2 Ophthalmic device with product code KYF cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K152996 · Innovative Ophthalmic Products, Inc. (Iop) · Ophthalmic device
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Dec 2015
Decision
65d
Days
Class 2
Risk

K152996 is an FDA 510(k) clearance for the Molteno3 Glaucoma Implant. Classified as Implant, Eye Valve (product code KYF), Class II - Special Controls.

Submitted by Innovative Ophthalmic Products, Inc. (Iop) (Costa Mesa, US). The FDA issued a Cleared decision on December 17, 2015 after a review of 65 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 Innovative Ophthalmic Products, Inc. (Iop) devices

FDA 510(k) Submission Details - K152996

510(k) Number K152996 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 2015
Decision Date December 17, 2015
Days to Decision 65 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 110d · This submission: 65d
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 Consultant

Arent Fox, Llp
JAMES R RAVITZ

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KYF Implant, Eye Valve

All 15
Devices cleared under the same product code (KYF) and FDA review panel - the closest regulatory comparables to K152996.
Ahmed Glaucoma Valve Model FP8
K171451 · New World Medical, Inc. · Aug 2017
XEN Glaucoma Treatment System
K161457 · Allergan, Inc. · Nov 2016
Ahmed Glaucoma Valve
K162060 · New World Medical, Inc. · Oct 2016
MOLTENO3
K062252 · Iop, Inc. · Sep 2006
AHMED GLAUCOMA VALVE, MODEL M4
K060644 · New World Medical, Inc. · Sep 2006
AHMED GLAUCOMA VALVE IMPLANT
K991072 · New World Medical, Inc. · Jul 1999