Cleared Traditional

K944994 - IOLAB/SITE DISPOSABLE DIAPHRAGM CASSETTE

K944994 is the FDA 510(k) clearance for IOLAB/SITE DISPOSABLE DIAPHRAGM CASSETTE by Chiron Vision Corp.. It is a Class 2 Ophthalmic device (product code HQC) cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K944994 · Chiron Vision Corp. · Ophthalmic device
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Optimized for regulatory review, auditing and printing
Mar 1995
Decision
153d
Days
Class 2
Risk

K944994 is an FDA 510(k) clearance for the IOLAB/SITE DISPOSABLE DIAPHRAGM CASSETTE. Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by Chiron Vision Corp. (Irvine, US). The FDA issued a Cleared decision on March 14, 1995 after a review of 153 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4670 - 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 Chiron Vision Corp. devices

Submission Details

510(k) Number K944994 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 1994
Decision Date March 14, 1995
Days to Decision 153 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
43d slower than avg
Panel avg: 110d · This submission: 153d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HQC Unit, Phacofragmentation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4670
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - HQC Unit, Phacofragmentation

All 98
Devices cleared under the same product code (HQC) and FDA review panel - the closest regulatory comparables to K944994.
STOTZ PROTEGE(TM) MICROSURGICAL SYSTEM
K950114 · Storz Instrument Co. · Jun 1995
AOI UNIVERSAL ULTRASONIC HANDPIECE
K950880 · American Optical Corp. · May 1995
STORZ PREMIERE(R) MICROSURGICAL SYSTEM
K946227 · Storz Instrument Co. · Mar 1995
STORZ PHACOEMULSIFICATION NEEDLES
K946176 · Storz Instrument Co. · Feb 1995
STORZ PHACO AND FRAG HANDPIECES
K935926 · Storz Instrument Co. · Nov 1994
P4000 PHACOEMULSIFIER
K931354 · American Optical Corp. · Feb 1994