Cleared Traditional

BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm) (K201983) - FDA 510(k) Clearance

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

K201983 · Med-El Elektromedizinische Geraete GmbH · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2020
Decision
84d
Days
Class 2
Risk

K201983 is an FDA 510(k) clearance for the BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4.... 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 October 9, 2020 after a review of 84 days - a notably fast clearance cycle.

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: 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 Med-El Elektromedizinische Geraete GmbH devices

Submission Details

510(k) Number K201983 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 2020
Decision Date October 09, 2020
Days to Decision 84 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 89d · This submission: 84d
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 K201983.
Sentio Ti Implant Kit
K240614 · Oticon Medical AB · Jul 2024
Cochlear Osia System
K240155 · Cochlear Americas · Apr 2024
Cochlear™ Osia® System
K231204 · Cochlear · Aug 2023
Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear MRI Kit
K220922 · Cochlear Americas · Jul 2022
BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote
K200504 · Med-El Elektromedizinische Geraete GmbH · Jul 2020
Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments
K191921 · Cochlear Americas · Nov 2019