Cleared Traditional

K051487 - DRG LARYNGEAL AUGMENTATION IMPLANT DEVICE (FDA 510(k) Clearance)

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K051487 · Doctor'S Research Group, Inc. · Ear, Nose, Throat device
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Dec 2005
Decision
199d
Days
Class 2
Risk

K051487 is an FDA 510(k) clearance for the DRG LARYNGEAL AUGMENTATION IMPLANT DEVICE. Classified as Polymer, Ent Synthetic-polyamide (mesh Or Foil Material) (product code KHJ), Class II - Special Controls.

Submitted by Doctor'S Research Group, Inc. (Plymouth, US). The FDA issued a Cleared decision on December 22, 2005 after a review of 199 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3620 - the FDA ear, nose and throat 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 Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K051487 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 2005
Decision Date December 22, 2005
Days to Decision 199 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
110d slower than avg
Panel avg: 89d · This submission: 199d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KHJ Polymer, Ent Synthetic-polyamide (mesh Or Foil Material)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3620
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 Ear, Nose, Throat devices follow this clearance model.