Atlas FDA

Cordelle II Sound Processor

FDA 510(k) clearance K150751 · decided 2015-07-22

Clearance details

K-number
K150751
Device name
Cordelle II Sound Processor
Applicant
Cochlear Americas
Decision
Substantially Equivalent
Date received
2015-03-23
Decision date
2015-07-22
Days to decision
121 days
Clearance type
Traditional
Product code
LXB
Device class
2
Regulation number
874.3302
Medical specialty
Ear, Nose, Throat
Advisory committee
Ear, Nose, Throat
Location
Centennial, CO, US
Third-party review
No
Expedited review
No

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Devices cleared under the same product code - the starting set for predicate research.

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Ossiclear (Ossiclear System) (K254296)Sounduct2026-07-22
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Ponto 5 SuperPower (K213733)Oticon Medical AB2021-12-16
Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App (K212136)Cochlear Americas2021-09-29
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Ponto 4 (K190540)Oticon Medical AB2019-05-02
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Cochlear Baha SoundArc (K171088)Cochlear Americas2017-06-07

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S240)Cochlear Americas2025-12-19
Nucleus® Hybrid™ L24 Cochlear Implant System (P130016/S058)Cochlear Americas2025-10-16
Nucleus® 24 Cochlear Implant System (P970051/S236)Cochlear Americas2025-10-16
Nucleus® 24 Cochlear Implant System (P970051/S238)Cochlear Americas2025-09-26
Cochlear™ Nucleus® System (P970051/S237)Cochlear Americas2025-09-02
Nucleus® 24 Cochlear Implant System (P970051/S235)Cochlear Americas2025-08-06
Nucleus® 24 Cochlear Implant System (P970051/S234)Cochlear Americas2025-07-24
Nucleus® 22 Cochlear Implant System (P890027/S064)Cochlear Americas2025-07-03