Cleared Traditional

K090720 - COCHLEAR BAHA BP100

K090720 is an FDA 510(k) clearance for COCHLEAR BAHA BP100, manufactured by Cochlear Bone Anchored Systems AB. The device is a Class 2 Ear, Nose, Throat device with product code LXB cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K090720 · Cochlear Bone Anchored Systems AB · Ear, Nose, Throat device
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Jun 2009
Decision
91d
Days
Class 2
Risk

K090720 is an FDA 510(k) clearance for the COCHLEAR BAHA BP100. Classified as Hearing Aid, Bone Conduction (product code LXB), Class II - Special Controls.

Submitted by Cochlear Bone Anchored Systems AB (Centennial, US). The FDA issued a Cleared decision on June 17, 2009 after a review of 91 days - within the typical 510(k) review window.

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: 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 Cochlear Bone Anchored Systems AB devices

FDA 510(k) Submission Details - K090720

510(k) Number K090720 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2009
Decision Date June 17, 2009
Days to Decision 91 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
1d slower than avg
Panel avg: 90d · This submission: 91d
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 48
Devices cleared under the same product code (LXB) and FDA review panel - the closest regulatory comparables to K090720.
BIA300 SERIES IMPLANT AND ABUTMENT, BI300 IMPLANT, BA300 ABUTMENT
K100360 · Cochlear Americas · Jul 2010
OTOMAG BONE CONDUCTION HEARING SYSTEM
K100193 · Sophono, Inc. · May 2010
PONTO PRO
K090996 · Oticon Medical AB · Jul 2009
OBC BONE ANCHORED HEARING AID SYSTEM
K082108 · Oticon Medical AB · Nov 2008
BAHA INTENSO
K081606 · Cochlear Americas · Aug 2008
TRANSEAR BONE CONDUCTION HEARING AID
K062404 · Ear Technology Corp. · Sep 2006