Cleared Traditional

K840181 - CATAREX/ULTRASONICS KIT

K840181 is the FDA 510(k) clearance for CATAREX/ULTRASONICS KIT by Calliope Corp.. It is a Class 2 Ophthalmic device (product code HQC) cleared through the Traditional 510(k) pathway after a 262-day FDA review.

K840181 · Calliope Corp. · Ophthalmic device
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Oct 1984
Decision
262d
Days
Class 2
Risk

K840181 is an FDA 510(k) clearance for the CATAREX/ULTRASONICS KIT. Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by Calliope Corp. (Mchenry, US). The FDA issued a Cleared decision on October 5, 1984 after a review of 262 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 Calliope Corp. devices

Submission Details

510(k) Number K840181 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 1984
Decision Date October 05, 1984
Days to Decision 262 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
152d slower than avg
Panel avg: 110d · This submission: 262d
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 113
Devices cleared under the same product code (HQC) and FDA review panel - the closest regulatory comparables to K840181.
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