Cleared Traditional

K011438 - BILATERAL FITTING OF THE BRANEMARK BONE...

K011438 is an FDA 510(k) clearance for BILATERAL FITTING OF THE BRANEMARK BONE..., manufactured by Entific Medical Systems, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code LXB cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K011438 · Entific Medical Systems, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2001
Decision
74d
Days
Class 2
Risk

K011438 is an FDA 510(k) clearance for the BILATERAL FITTING OF THE BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM.. Classified as Hearing Aid, Bone Conduction (product code LXB), Class II - Special Controls.

Submitted by Entific Medical Systems, Inc. (Findley, US). The FDA issued a Cleared decision on July 23, 2001 after a review of 74 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 Entific Medical Systems, Inc. devices

FDA 510(k) Submission Details - K011438

510(k) Number K011438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2001
Decision Date July 23, 2001
Days to Decision 74 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
15d faster than avg
Panel avg: 89d · This submission: 74d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LXB Device Classification - Class 2, Special Controls

Product Code LXB Hearing Aid, Bone Conduction
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.

Regulatory Peers - LXB Hearing Aid, Bone Conduction

All 16
Devices cleared under the same product code (LXB) and FDA review panel - the closest regulatory comparables to K011438.
Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart App
K202048 · Cochlear Americas · Feb 2021
Ponto 4
K190540 · Oticon Medical AB · May 2019
ADHEAR System
K172460 · Med-El Elektromedizinische Geraete GmbH · Apr 2018
NOBELPHARMA BONE ANCHORED HEARING AID
K955713 · Nobelpharma USA, Inc. · Aug 1996
VIENNATONE AN, VIENNATONE AS FIDELITY F228, FIDELITY F229
K935701 · Starkey Laboratories, Inc. · May 1994
MODIFIED IMPLANT FOR XOMED AUDIANT BONE CONDUCTOR
K884056 · Xomed, Inc. · Nov 1988