Cleared Traditional

BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm) (K191457) - FDA 510(k) Clearance

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

K191457 · Med-El Elektromedizinische Geraete GmbH · Ear, Nose, Throat device
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Sep 2019
Decision
110d
Days
Class 2
Risk

K191457 is an FDA 510(k) clearance for the BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602.... Classified as Active Implantable Bone Conduction Hearing System (product code PFO), Class II - Special Controls.

Submitted by Med-El Elektromedizinische Geraete GmbH (Innsbruck, AT). The FDA issued a Cleared decision on September 18, 2019 after a review of 110 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3340 - 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.

View all Med-El Elektromedizinische Geraete GmbH devices

Submission Details

510(k) Number K191457 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 2019
Decision Date September 18, 2019
Days to Decision 110 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 89d · This submission: 110d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PFO Active Implantable Bone Conduction Hearing System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3340
Definition An Active Implantable Bone Conduction Hearing System Is A Prescription Device Consisting Of An Implanted Transducer, Implanted Electronics Components, And An Audio Processor. The Active Implantable Bone Conduction Hearing System Is Intended To Compensate For Conductive Or Mixed Hearing Losses By Conveying Amplified Acoustic Signals To The Cochlea Via Mechanical Vibrations On The Skull Bone.
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.

Regulatory Peers - PFO Active Implantable Bone Conduction Hearing System

All 10
Devices cleared under the same product code (PFO) and FDA review panel - the closest regulatory comparables to K191457.
Sentio Ti Implant Kit
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BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm)
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BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote
K200504 · Med-El Elektromedizinische Geraete GmbH · Jul 2020