Cleared Traditional

K150751 - Cordelle II Sound Processor

K150751 is an FDA 510(k) clearance for Cordelle II Sound Processor, 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 121-day FDA review.

K150751 · Cochlear Americas · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2015
Decision
121d
Days
Class 2
Risk

K150751 is an FDA 510(k) clearance for the Cordelle II Sound Processor. 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 22, 2015 after a review of 121 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 Americas devices

FDA 510(k) Submission Details - K150751

510(k) Number K150751 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2015
Decision Date July 22, 2015
Days to Decision 121 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
31d slower than avg
Panel avg: 90d · This submission: 121d
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 K150751.
Sophono Bone Conduction Systems (S) Configuration and (M) Configuration
K153391 · Sophono, Inc. · Jun 2016
Baha 5 Power Sound Processor
K161123 · Cochlear Americas · May 2016
Baha 5 Super Power Sound Processor
K153245 · Cochlear Americas · Mar 2016
Baha 5 Sound Processor
K142907 · Cochlear Americas · Mar 2015
PONTO PLUS AND PONTO PLUS POWER
K132775 · Oticon Medical AB · Dec 2013
OTOMAG BONE CONDUCATION HEARING SYSTEM
K132189 · Sophono, Inc. · Nov 2013