Atlas FDA

Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

Cochlear Americas — Predicate Candidate Screening

21 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

118 daysmedian FDA review time
170 days90th percentile
21clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K260902Cochlear™ Osia® 3(I) Sound Processor;Cochlear™ Osia® 3 SoundCochlear Americas2026-07-101140
K240155Cochlear Osia SystemCochlear Americas2024-04-18900
K231604Instrument CaseCochlear Americas2023-08-24840
K220922Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, CochleCochlear Americas2022-07-271180
K212136Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, CoCochlear Americas2021-09-29830
K202048Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting SCochlear Americas2021-02-232140
K191921Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound ProcessoCochlear Americas2019-11-151200
K190589Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor,Cochlear Americas2019-07-031180
K182116BA310 Abutment, BIA310 Implant/AbutmentCochlear Americas2018-12-191350
K171088Cochlear Baha SoundArcCochlear Americas2017-06-07560
K161123Baha 5 Power Sound ProcessorCochlear Americas2016-05-20290
K153245Baha 5 Super Power Sound ProcessorCochlear Americas2016-03-021140
K150751Cordelle II Sound ProcessorCochlear Americas2015-07-221210
K150555BA400 14mm AbutmentCochlear Americas2015-07-151330
K142907Baha 5 Sound ProcessorCochlear Americas2015-03-251700
K131240COCHLEAR BAHA IMPLANT SYSTEM, COCHLEAR BAHA ATTRACTCochlear Americas2013-11-071901
K132278COCHLEAR BAHA 4 SOUND PROCESSORCochlear Americas2013-09-26650
K121317COCHLEAR BAHA IMPLANT SYSTEMCochlear Americas2012-10-121630
K110996BAHA 3 POWER SOUND PROCESSORCochlear Americas2011-05-10290
K100360BIA300 SERIES IMPLANT AND ABUTMENT, BI300 IMPLANT, BA300 ABUCochlear Americas2010-07-131510
K081606BAHA INTENSOCochlear Americas2008-08-28830

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda