Cleared Traditional

K881682 - ALCON SITE(R)-COMPATIBLE CASSETTE

K881682 is an FDA 510(k) clearance for ALCON SITE-COMPATIBLE CASSETTE, manufactured by Alcon Laboratories. The device is a Class 1 Ophthalmic device with product code KYG cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K881682 · Alcon Laboratories · Ophthalmic device
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Jul 1988
Decision
73d
Days
Class 1
Risk

K881682 is an FDA 510(k) clearance for the ALCON SITE(R)-COMPATIBLE CASSETTE. Classified as Device, Irrigation, Ocular Surgery (product code KYG), Class I - General Controls.

Submitted by Alcon Laboratories (Fort Worth, US). The FDA issued a Cleared decision on July 1, 1988 after a review of 73 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.

FDA 510(k) Submission Details - K881682

510(k) Number K881682 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 1988
Decision Date July 01, 1988
Days to Decision 73 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
37d faster than avg
Panel avg: 110d · This submission: 73d
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 37
Devices cleared under the same product code (KYG) and FDA review panel - the closest regulatory comparables to K881682.
B & B I/A HANDPIECE
K881517 · B&B Medical Assoc., Inc. · Aug 1988
INFUSION HANDLE
K881518 · B&B Medical Assoc., Inc. · Aug 1988
UNI-PORT
K880543 · Surgeon Surgical Instrumentation, Inc. · Jul 1988
MORGAN THERAPEUTIC LENS
K871454 · Mortan, Inc. · Jun 1987
MULTI-SPIKE
K861203 · Surgeon Surgical Instrumentation, Inc. · Apr 1986
BACSTOP FILTER IRRIGATION SUPPLY KIT
K860544 · Staar Surgical Co. · Apr 1986
K881682 · ALCON SITE(R)-COMPATIBLE CASSETTE
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