Cleared Traditional

K843992 - CILCOR OPHTHALMIC INSTRUMENTS (FDA 510(k) Clearance)

Class I Ophthalmic device.

K843992 · Cilco, Inc. · Ophthalmic device
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Nov 1984
Decision
41d
Days
Class 1
Risk

K843992 is an FDA 510(k) clearance for the CILCOR OPHTHALMIC INSTRUMENTS. Classified as Forceps, Ophthalmic (product code HNR), Class I - General Controls.

Submitted by Cilco, Inc. (Huntington, US). The FDA issued a Cleared decision on November 21, 1984 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4350 - 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 Cilco, Inc. devices

Submission Details

510(k) Number K843992 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1984
Decision Date November 21, 1984
Days to Decision 41 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 110d · This submission: 41d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HNR Forceps, Ophthalmic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4350
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.