Cleared Traditional

K840965 - SITE COAXIAL I/A HANDPIECE 30 TIP

K840965 is the FDA 510(k) clearance for SITE COAXIAL I/A HANDPIECE 30 TIP by Chiron Vision Corp.. It is a Class 2 Ophthalmic device (product code HQC) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K840965 · Chiron Vision Corp. · Ophthalmic device
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May 1984
Decision
64d
Days
Class 2
Risk

K840965 is an FDA 510(k) clearance for the SITE COAXIAL I/A HANDPIECE 30 TIP. 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 May 9, 1984 after a review of 64 days - a notably fast clearance 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: 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 K840965 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 1984
Decision Date May 09, 1984
Days to Decision 64 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 110d · This submission: 64d
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 K840965.
IOCARE ULTRASONIC TITANIUM TIPS
K843278 · Chiron Vision Corp. · Nov 1984
MENDEZ U/S CYSTOTOME
K843386 · CooperVision, Inc. · Nov 1984
SITE SIMCOE STYLE I/A HANDPIECE
K842458 · Chiron Vision Corp. · Aug 1984
IOCARE IRRIGATION & ASPIRATION PACK
K834340 · Chiron Vision Corp. · Apr 1984
DISPOSABLE FIBER OPTIC ILLUMINATOR
K833465 · CooperVision, Inc. · Mar 1984
DISPOS. I/A & IRRIGATION HANDPIECES
K833783 · CooperVision, Inc. · Mar 1984