Cleared Traditional

DUCKWORTH & KENT LTD INJECTOR, MODEL: DK7797-2 (K072985) - FDA 510(k) Clearance

Class I Ophthalmic device.

K072985 · Duckworth & Kent, Ltd. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2008
Decision
241d
Days
Class 1
Risk

K072985 is an FDA 510(k) clearance for the DUCKWORTH & KENT LTD INJECTOR, MODEL: DK7797-2. Classified as Lens, Guide, Intraocular (product code KYB), Class I - General Controls.

Submitted by Duckworth & Kent, Ltd. (Baldock, Hertfordshire, GB). The FDA issued a Cleared decision on June 20, 2008 after a review of 241 days - an extended review cycle.

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.

View all Duckworth & Kent, Ltd. devices

Submission Details

510(k) Number K072985 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 2007
Decision Date June 20, 2008
Days to Decision 241 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
131d slower than avg
Panel avg: 110d · This submission: 241d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KYB Lens, Guide, Intraocular
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.