Cleared Traditional

K853243 - VISITEC IRRIGATION CONTROL SYSTEM

K853243 is an FDA 510(k) clearance for VISITEC IRRIGATION CONTROL SYSTEM, manufactured by Visitec Co.. The device is a Class 1 Ophthalmic device with product code KYG cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K853243 · Visitec Co. · Ophthalmic device
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Sep 1985
Decision
41d
Days
Class 1
Risk

K853243 is an FDA 510(k) clearance for the VISITEC IRRIGATION CONTROL SYSTEM. Classified as Device, Irrigation, Ocular Surgery (product code KYG), Class I - General Controls.

Submitted by Visitec Co. (Sarasota, US). The FDA issued a Cleared decision on September 11, 1985 after a review of 41 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 Visitec Co. devices

FDA 510(k) Submission Details - K853243

510(k) Number K853243 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1985
Decision Date September 11, 1985
Days to Decision 41 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
69d faster than avg
Panel avg: 110d · This submission: 41d
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 10
Devices cleared under the same product code (KYG) and FDA review panel - the closest regulatory comparables to K853243.
AQUEOUS PARACENTESIS PIPET
K915808 · Visitec Co. · Mar 1992
SITE DIAPHRAGM CASSETTE
K904186 · Site Microsurgical Systems, Inc. · Nov 1990
ALCON SITE(R)-COMPATIBLE CASSETTE
K881682 · Alcon Laboratories · Jul 1988
OPERAID DISPOS. IRRIGATING KNIFE
K845039 · Jedmed Instrument Co. · Mar 1985
OPERAID NUCLEUS
K841807 · Jedmed Instrument Co. · Nov 1984
ELECATH HEPARIN COATED THERMAL DILUTION
K832787 · Electro-Catheter Corp. · Oct 1983