Cleared Traditional

K925921 - MODIFIED SITE DISPOSABLE DIAPHRAGM CASS...

K925921 is the FDA 510(k) clearance for MODIFIED SITE DISPOSABLE DIAPHRAGM CASS... by Site Microsurgical Systems, Inc.. It is a Class 1 Ophthalmic device (product code KYG) cleared through the Traditional 510(k) pathway after a 378-day FDA review.

K925921 · Site Microsurgical Systems, Inc. · Ophthalmic device
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Dec 1993
Decision
378d
Days
Class 1
Risk

K925921 is an FDA 510(k) clearance for the MODIFIED SITE DISPOSABLE DIAPHRAGM CASSETTE. Classified as Device, Irrigation, Ocular Surgery (product code KYG), Class I - General Controls.

Submitted by Site Microsurgical Systems, Inc. (Horsham, US). The FDA issued a Cleared decision on December 6, 1993 after a review of 378 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Site Microsurgical Systems, Inc. devices

Submission Details

510(k) Number K925921 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 1992
Decision Date December 06, 1993
Days to Decision 378 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
268d slower than avg
Panel avg: 110d · This submission: 378d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 9
Devices cleared under the same product code (KYG) and FDA review panel - the closest regulatory comparables to K925921.
SOVEREIGN CATARACT EXTRACTION SYSTEM
K981116 · Allergan, Inc. · May 1998
MODIFIED SITE DIAPHRAGM CASSETTE FOR OPHTHALMICS
K922996 · Chiron Vision Corp. · Jul 1992
AQUEOUS PARACENTESIS PIPET
K915808 · Visitec Co. · Mar 1992
ALCON SITE(R)-COMPATIBLE CASSETTE
K881682 · Alcon Laboratories · Jul 1988
VISITEC IRRIGATION CONTROL SYSTEM
K853243 · Visitec Co. · Sep 1985
OPERAID DISPOS. IRRIGATING KNIFE
K845039 · Jedmed Instrument Co. · Mar 1985