510(k) Report

Devices descending from K190589

5 later devices reach Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191921Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software…Cochlear Americas20194—
+2K220922Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor…Cochlear Americas20223—
+3K231204Cochlear™ Osia® System; Cochlear™ Osia® OSI300 Implant; Cochlear™ Magnet Cassette…Cochlear20232—
+4K240155Cochlear Osia SystemCochlear Americas20241—
+5K260902Cochlear™ Osia® 3(I) Sound Processor;Cochlear™ Osia® 3 Sound Processor;Cochlear™ Osia® 3…Cochlear Americas20260—