Cleared Traditional

K944995 - IOLAB/SITE PERISTALTIC MODULE

K944995 is the FDA 510(k) clearance for IOLAB/SITE PERISTALTIC MODULE by Chiron Vision Corp.. It is a Class 2 Ophthalmic device (product code HQC) cleared through the Traditional 510(k) pathway after a 358-day FDA review.

K944995 · Chiron Vision Corp. · Ophthalmic device
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Oct 1995
Decision
358d
Days
Class 2
Risk

K944995 is an FDA 510(k) clearance for the IOLAB/SITE PERISTALTIC MODULE. 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 October 5, 1995 after a review of 358 days - an unusually long review period, suggesting complex equivalence evaluation.

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. 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 Chiron Vision Corp. devices

Submission Details

510(k) Number K944995 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 1994
Decision Date October 05, 1995
Days to Decision 358 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
248d slower than avg
Panel avg: 110d · This submission: 358d
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 K944995.
ALCON SERIES 20000 LEGACY MACKOOL SYSTEM
K955789 · Alcon Laboratories · Mar 1996
STORZ I/A HANDPIECES
K951463 · Storz Instrument Co. · Oct 1995
IOLAB.SITE CD PHACOEMULSIFICATION MODULE
K944993 · Chiron Vision Corp. · Oct 1995
PHACO TIP
K950881 · American Optical Corp. · Sep 1995
ALCON SERIES 20000 LEGACY PHACOEMULSIFIER
K952213 · Alcon Laboratories · Aug 1995
STORZ DP4101 BASIC I/A PACK
K953078 · Storz Instrument Co. · Aug 1995