Cleared Traditional

BAHA CORDELLE II (K080363) - FDA 510(k) Clearance

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

K080363 · Cochlear Bone Anchored Systems AB · Ear, Nose, Throat device
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Apr 2008
Decision
59d
Days
Class 2
Risk

K080363 is an FDA 510(k) clearance for the BAHA CORDELLE II. Classified as Hearing Aid, Bone Conduction, Implanted (product code MAH), Class II - Special Controls.

Submitted by Cochlear Bone Anchored Systems AB (Englewood, US). The FDA issued a Cleared decision on April 10, 2008 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3302 - 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: 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 Cochlear Bone Anchored Systems AB devices

Submission Details

510(k) Number K080363 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2008
Decision Date April 10, 2008
Days to Decision 59 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
30d faster than avg
Panel avg: 89d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MAH Hearing Aid, Bone Conduction, Implanted
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3302
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.