510(k) Report

Devices descending from K090720

33 later devices reach Cochlear Baha BP100 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171088Cochlear Baha SoundArcCochlear Americas20170—
+1K132278Cochlear Baha 4 Sound ProcessorCochlear Americas201311—
+1K121228Ponto Bone Anchored Hearing SystemOticon Medical AB20124—
+1K110831Soundbite Hearing System by Sonitus MedicalSonitus Medical, Inc.201105
+1K103594Ponto Pro PowerOticon Medical AB201111—
+1K100649Soundbite Hearing System by SonitusSonitus Medical, Inc.20111—
+1K100193Otomag Bone Conduction Hearing SystemSophono, Inc.20105—
+2K152067Ponto bone anchored hearing systemOticon Medical AB20151—
+2K142907Baha 5 Sound ProcessorCochlear Americas2015101
+2K142678Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone Anchored Hearing System /…Oticon Medical AB20153—
+2K132775Ponto Plus and Ponto Plus PowerOticon Medical AB201310—
+2K102199Otomag Bone Conduction Hearing System Model Alpha 1 (S) and Alpha 1 (M)Sophono, Inc.20114—
+3K203807Ponto Bone Anchored Hearing System, MONO Surgery KitOticon Medical AB20210—
+3K172460ADHEAR SystemMed-El Elektromedizinische Geraete GmbH20181—
+3K161671Ponto 3, Ponto 3 Power and Ponto 3 SuperPowerOticon Medical AB20165—
+3K161123Baha 5 Power Sound ProcessorCochlear Americas20166—
+3K153245Baha 5 Super Power Sound ProcessorCochlear Americas20161—
+3K152820Ponto Bone Anchored Hearing SystemOticon Medical AB20160—
+3K132189Otomag Bone Conducation Hearing SystemSophono, Inc.20132—
+3K123962Otomag Bone Conduction Hearing SystemSophono, Inc.20130—
+4K253431Bone conduction Hearing Aid (BM100, BM300, BM310, SHOKZHEAR BM400, SHOKZ BM400MN…Shokz Health Global Limited20260—
+4K260452Bone Conduction Hearing Aid (G41157, G41158, G41159, G41160, G42151, G42152, G42153…Zdeer Technology (Henan) Co., Ltd.20260—
+4K213733Ponto 5 SuperPowerOticon Medical AB20211—
+4K202048Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha…Cochlear Americas20213—
+4K190540Ponto 4Oticon Medical AB20193—
+4K182116BA310 Abutment, BIA310 Implant/AbutmentCochlear Americas20180—
+4K153391Sophono Bone Conduction Systems (S) Configuration and (M) ConfigurationSophono, Inc.20161—
+5K261142Ponto 5 Mini; Ponto 5 SuperpowerOticon Medical AB20260—
+5K250215Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS)…Cochlear20250—
+5K243041contact forte AlphaBhm-Tech Produktionsgesellschaft Mbh20250—
+5K212136Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart AppCochlear Americas20211—
+5K211640Ponto 5 MiniOticon Medical AB20212—
+6K254296Ossiclear (Ossiclear System)Sounduct20260—