Cleared Traditional

K843319 - CILCO I/A SURGICAL PACK

K843319 is an FDA 510(k) clearance for CILCO I/A SURGICAL PACK, manufactured by Cilco, Inc.. The device is a Class 2 Ophthalmic device with product code HQC cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K843319 · Cilco, Inc. · Ophthalmic device
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Feb 1985
Decision
174d
Days
Class 2
Risk

K843319 is an FDA 510(k) clearance for the CILCO I/A SURGICAL PACK. Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by Cilco, Inc. (Huntington, US). The FDA issued a Cleared decision on February 14, 1985 after a review of 174 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 Cilco, Inc. devices

FDA 510(k) Submission Details - K843319

510(k) Number K843319 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 1984
Decision Date February 14, 1985
Days to Decision 174 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d slower than avg
Panel avg: 110d · This submission: 174d
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 198
Devices cleared under the same product code (HQC) and FDA review panel - the closest regulatory comparables to K843319.
I/A BAC STOP KIT
K850899 · Staar Surgical Co. · Mar 1985
PHACO-BAC STOP KIT
K850900 · Staar Surgical Co. · Mar 1985
VISITEC OPHTHALMIC FLUID DISTRIB- SET
K843487 · Visitec Co. · Mar 1985
SITE ULTRASONIC EMULSIFICATION MODULE OP
K844666 · Chiron Vision Corp. · Dec 1984
COOPERVISION SYSTEM VI
K842945 · CooperVision, Inc. · Dec 1984
MEDICAL OPTICS PHACOEMULSIFICATION KIT
K844150 · American Medical Optics · Dec 1984