Cleared Traditional

K954842 - D.O.R.C. VFI/VFE SYSTEM

K954842 is an FDA 510(k) clearance for D.O.R.C. VFI/VFE SYSTEM, manufactured by Dutch Ophthalmic USA, Inc.. The device is a Class 1 Ophthalmic device with product code KYG cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K954842 · Dutch Ophthalmic USA, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1996
Decision
175d
Days
Class 1
Risk

K954842 is an FDA 510(k) clearance for the D.O.R.C. VFI/VFE SYSTEM. Classified as Device, Irrigation, Ocular Surgery (product code KYG), Class I - General Controls.

Submitted by Dutch Ophthalmic USA, Inc. (Kingston, US). The FDA issued a Cleared decision on April 15, 1996 after a review of 175 days - an extended review 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: 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 Dutch Ophthalmic USA, Inc. devices

FDA 510(k) Submission Details - K954842

510(k) Number K954842 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1995
Decision Date April 15, 1996
Days to Decision 175 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d slower than avg
Panel avg: 110d · This submission: 175d
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 11
Devices cleared under the same product code (KYG) and FDA review panel - the closest regulatory comparables to K954842.
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ALCON SITE(R)-COMPATIBLE CASSETTE
K881682 · Alcon Laboratories · Jul 1988