Cleared Traditional

K922996 - MODIFIED SITE DIAPHRAGM CASSETTE FOR OP...

K922996 is the FDA 510(k) clearance for MODIFIED SITE DIAPHRAGM CASSETTE FOR OP... by Chiron Vision Corp.. It is a Class 1 Ophthalmic device (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)
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.

View all Chiron Vision Corp. devices

Submission Details

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.

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 8
Devices cleared under the same product code (KYG) and FDA review panel - the closest regulatory comparables to K922996.
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