Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

PFO — Predicate Candidate Screening

12 FDA 510(k) clearances under this product code; the 50 most recent screened below.

118 daysmedian FDA review time
149 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K260902Cochlear™ Osia® 3(I) Sound Processor;Cochlear™ Osia® 3 SoundCochlear Americas2026-07-101140
K240614Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHSOticon Medical AB2024-07-101270
K240155Cochlear Osia SystemCochlear Americas2024-04-18900
K231204Cochlear™ Osia® System; Cochlear™ Osia® OSI300 Implant; CochCochlear2023-08-181130
K220922Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, CochleCochlear Americas2022-07-271180
K201983BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 Med-El Elektromedizinische Geraete GmbH2020-10-09840
K200504BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBAMed-El Elektromedizinische Geraete GmbH2020-07-291490
K191921Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound ProcessoCochlear Americas2019-11-151200
K191457BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 ImplMed-El Elektromedizinische Geraete GmbH2019-09-181100
K190589Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor,Cochlear Americas2019-07-031180
K183373BonebridgeMed-El Elektromedizinische Geraete GmbH2019-03-07910
DEN170009BonebridgeMed-El Elektromedizinische Geraete GmbH2018-07-205220

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