Cleared Traditional

K161457 - XEN Glaucoma Treatment System

K161457 is an FDA 510(k) clearance for XEN Glaucoma Treatment System, manufactured by Allergan, Inc.. The device is a Class 2 Ophthalmic device with product code KYF cleared through the Traditional 510(k) pathway after a 179-day FDA review.

K161457 · Allergan, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2016
Decision
179d
Days
Class 2
Risk

K161457 is an FDA 510(k) clearance for the XEN Glaucoma Treatment System. Classified as Implant, Eye Valve (product code KYF), Class II - Special Controls.

Submitted by Allergan, Inc. (Aliso Viejo, US). The FDA issued a Cleared decision on November 21, 2016 after a review of 179 days - an extended review 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: 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 Allergan, Inc. devices

FDA 510(k) Submission Details - K161457

510(k) Number K161457 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 2016
Decision Date November 21, 2016
Days to Decision 179 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
69d slower than avg
Panel avg: 110d · This submission: 179d
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 13
Devices cleared under the same product code (KYF) and FDA review panel - the closest regulatory comparables to K161457.
iStent infinite Trabecular Micro-Bypass System, Model iS3
K220032 · Glaukos Corporation · Aug 2022
AHMED ClearPath Glaucoma Drainage Device
K182518 · New World Medical, Inc. · Jan 2019
Ahmed Glaucoma Valve Model FP8
K171451 · New World Medical, Inc. · Aug 2017
Ahmed Glaucoma Valve
K162060 · New World Medical, Inc. · Oct 2016
Molteno3 Glaucoma Implant
K152996 · Innovative Ophthalmic Products, Inc. (Iop) · Dec 2015
AHMED GLAUCOMA VALVE IMPLANT
K991072 · New World Medical, Inc. · Jul 1999