Cleared Traditional

K922996 - MODIFIED SITE DIAPHRAGM CASSETTE FOR OPHTHALMICS

K922996 is an FDA 510(k) clearance for MODIFIED SITE DIAPHRAGM CASSETTE FOR OP..., manufactured by Chiron Vision Corp.. The device is a Class 1 Ophthalmic device with product code KYG cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K922996 · Chiron Vision Corp. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 1992
Decision
35d
Days
Class 1
Risk

K922996 is an FDA 510(k) clearance for the MODIFIED SITE DIAPHRAGM CASSETTE FOR OPHTHALMICS. Classified as Device, Irrigation, Ocular Surgery (product code KYG), Class I - General Controls.

Submitted by Chiron Vision Corp. (Horsham, US). The FDA issued a Cleared decision on July 27, 1992 after a review of 35 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 - K922996

510(k) Number K922996 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1992
Decision Date July 27, 1992
Days to Decision 35 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 110d · This submission: 35d
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 39
Devices cleared under the same product code (KYG) and FDA review panel - the closest regulatory comparables to K922996.
MODIFIED SITE DISPOSABLE DIAPHRAGM CASSETTE
K925921 · Site Microsurgical Systems, Inc. · Dec 1993
AUTOPOLE REGULATOR SYSTEM
K924999 · Escalon Trek Medical · Dec 1992
INFINITY MICRO IRRIGATOR
K924052 · Infinity Surgical Technology, Inc. · Dec 1992
LEWICKY O.R.S. TUBING
K922180 · O.R. Specialties, Inc. · Jul 1992
AQUEOUS PARACENTESIS PIPET
K915808 · Visitec Co. · Mar 1992
GRIESHABER AIR/FLUID TUBING SET
K914587 · Grieshaber & Co. · Jan 1992
K922996 · MODIFIED SITE DIAPHRAGM CASSETTE FOR OPHTHALMICS
Download PDF FDA Summary Chiron Vision Corp.