Cleared Traditional

CAPSULE TENSION RING INSERTER, MODEL 7-810 (K042478) - FDA 510(k) Clearance

Class I Ophthalmic device.

K042478 · Duckworth & Kent, Ltd. · Ophthalmic device
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Dec 2004
Decision
106d
Days
Class 1
Risk

K042478 is an FDA 510(k) clearance for the CAPSULE TENSION RING INSERTER, MODEL 7-810. Classified as Injector, Capsular Tension Ring (product code NCE), Class I - General Controls.

Submitted by Duckworth & Kent, Ltd. (Baldock, Hertfordshire, GB). The FDA issued a Cleared decision on December 28, 2004 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4300 - 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.

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Submission Details

510(k) Number K042478 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2004
Decision Date December 28, 2004
Days to Decision 106 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 110d · This submission: 106d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NCE Injector, Capsular Tension Ring
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4300
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.