Cleared Traditional

K904186 - SITE DIAPHRAGM CASSETTE

K904186 is an FDA 510(k) clearance for SITE DIAPHRAGM CASSETTE, manufactured by Site Microsurgical Systems, Inc.. The device is a Class 1 Ophthalmic device with product code KYG cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K904186 · Site Microsurgical Systems, Inc. · Ophthalmic device
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Nov 1990
Decision
70d
Days
Class 1
Risk

K904186 is an FDA 510(k) clearance for the SITE 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 November 21, 1990 after a review of 70 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 Site Microsurgical Systems, Inc. devices

FDA 510(k) Submission Details - K904186

510(k) Number K904186 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1990
Decision Date November 21, 1990
Days to Decision 70 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
40d faster than avg
Panel avg: 110d · This submission: 70d
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 K904186.
MODIFIED SITE DISPOSABLE DIAPHRAGM CASSETTE
K925921 · Site Microsurgical Systems, Inc. · Dec 1993
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
BACSTOP FILTER IRRIGATION SUPPLY KIT
K860544 · Staar Surgical Co. · Apr 1986
ELECTRICALLY CONTROLLED I.V. POLE (OPTHALMIC)
K861013 · Ameritek, Inc. · Mar 1986