Cleared Traditional

K944995 - IOLAB/SITE PERISTALTIC MODULE

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

K944995 · Chiron Vision Corp. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K944995

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.

HQC Device Classification - Class 2, Special Controls

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 194
Devices cleared under the same product code (HQC) and FDA review panel - the closest regulatory comparables to K944995.
SURGIN GENISIS HANDPIECE
K954238 · Surgin Surgical Instrumentation, Inc. · Dec 1995
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