Cleared Traditional

K100360 - BIA300 SERIES IMPLANT AND ABUTMENT, BI300 IMPLANT, BA300 ABUTMENT

K100360 is an FDA 510(k) clearance for BIA300 SERIES IMPLANT AND ABUTMENT, manufactured by Cochlear Americas. The device is a Class 2 Ear, Nose, Throat device with product code LXB cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K100360 · Cochlear Americas · Ear, Nose, Throat device
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Jul 2010
Decision
151d
Days
Class 2
Risk

K100360 is an FDA 510(k) clearance for the BIA300 SERIES IMPLANT AND ABUTMENT, BI300 IMPLANT, BA300 ABUTMENT. Classified as Hearing Aid, Bone Conduction (product code LXB), Class II - Special Controls.

Submitted by Cochlear Americas (Centennial, US). The FDA issued a Cleared decision on July 13, 2010 after a review of 151 days - an extended review 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: 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 Americas devices

FDA 510(k) Submission Details - K100360

510(k) Number K100360 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2010
Decision Date July 13, 2010
Days to Decision 151 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
61d slower than avg
Panel avg: 90d · This submission: 151d
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 43
Devices cleared under the same product code (LXB) and FDA review panel - the closest regulatory comparables to K100360.
SOUNDBITE HEARING SYSTEM BY SONITUS MEDICAL
K110831 · Sonitus Medical, Inc. · Jun 2011
PONTO PRO POWER
K103594 · Oticon Medical AB · Jun 2011
BAHA 3 POWER SOUND PROCESSOR
K110996 · Cochlear Americas · May 2011
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