Cleared Traditional

K842458 - SITE SIMCOE STYLE I/A HANDPIECE

K842458 is an FDA 510(k) clearance for SITE SIMCOE STYLE I/A HANDPIECE, 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 54-day FDA review.

K842458 · Chiron Vision Corp. · Ophthalmic device
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Aug 1984
Decision
54d
Days
Class 2
Risk

K842458 is an FDA 510(k) clearance for the SITE SIMCOE STYLE I/A HANDPIECE. 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 August 15, 1984 after a review of 54 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.

FDA 510(k) Submission Details - K842458

510(k) Number K842458 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1984
Decision Date August 15, 1984
Days to Decision 54 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
56d faster than avg
Panel avg: 110d · This submission: 54d
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 316
Devices cleared under the same product code (HQC) and FDA review panel - the closest regulatory comparables to K842458.
MENDEZ U/S CYSTOTOME
K843386 · CooperVision, Inc. · Nov 1984
CATAREX VITRECUTTER I/A DISPOS. CUT
K840063 · Calliope Corp. · Oct 1984
CATAREX/ULTRASONICS KIT
K840181 · Calliope Corp. · Oct 1984
MANUAL IRRIGATING/ASPIRATING UNIT
K840495 · Alltek, Inc. · Jun 1984
PHACOEMULSIFICATION KITS
K840695 · Innovative Surgical Products, Inc. · May 1984
SITE COAXIAL I/A HANDPIECE 30 TIP
K840965 · Chiron Vision Corp. · May 1984
K842458 · SITE SIMCOE STYLE I/A HANDPIECE
Download PDF Chiron Vision Corp.