Cleared Traditional

K981116 - SOVEREIGN CATARACT EXTRACTION SYSTEM

K981116 is an FDA 510(k) clearance for SOVEREIGN CATARACT EXTRACTION SYSTEM, manufactured by Allergan, Inc.. The device is a Class 1 Ophthalmic device with product code KYG cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K981116 · Allergan, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1998
Decision
53d
Days
Class 1
Risk

K981116 is an FDA 510(k) clearance for the SOVEREIGN CATARACT EXTRACTION SYSTEM. Classified as Device, Irrigation, Ocular Surgery (product code KYG), Class I - General Controls.

Submitted by Allergan, Inc. (Irvine, US). The FDA issued a Cleared decision on May 19, 1998 after a review of 53 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4360 - 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 Allergan, Inc. devices

FDA 510(k) Submission Details - K981116

510(k) Number K981116 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 1998
Decision Date May 19, 1998
Days to Decision 53 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
57d faster than avg
Panel avg: 110d · This submission: 53d
Pathway characteristics
Predicate-based equivalence.

KYG Device Classification - Class 1, General Controls

Product Code KYG Device, Irrigation, Ocular Surgery
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4360
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KYG Device, Irrigation, Ocular Surgery

All 22
Devices cleared under the same product code (KYG) and FDA review panel - the closest regulatory comparables to K981116.
BLADEWORKS DISPOSABLE ALK TUBING
K993591 · Blade Works, Inc. · Dec 1999
EYE IRRIGATOR MODEL #2020
K980647 · Eye-Deal Ocular Safety Products, Inc. · May 1998
MOISTAIR FLUID AIR TUBING SET
K974561 · American Medical Devices, Inc. · Feb 1998
ML DISPOSABLE ALK TUBING
K971173 · Med-Logics, Inc. · May 1997
HEDGES CORNEAL WETTING PAK
K970161 · Hedges Cwp, Inc. · Mar 1997
D.O.R.C. VFI/VFE SYSTEM
K954842 · Dutch Ophthalmic USA, Inc. · Apr 1996