# PFO: Active Implantable Bone Conduction Hearing System

- Device class: 2; regulation: 21 CFR 874.3340; FDA's rule: 510(k) required
- FDA decisions: 12
- 510(k) review time 2021–2025: median 116 days (middle half 107–120)
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2018: 1
- 2019: 4
- 2020: 2
- 2022: 1
- 2023: 1
- 2024: 2
- 2026: 1

## Most-cited predicates
- DEN170009: Bonebridge (2018), cited by 4
- K191921: Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments (2019), cited by 1
- K191457: BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm) (2019), cited by 1
- K190589: Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia Fitting Software, Cochlear Osia Surgical Instruments (2019), cited by 1
- K220922: Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear MRI Kit (2022), cited by 1
- K231204: Cochlear™ Osia® System; Cochlear™ Osia® OSI300 Implant; Cochlear™ Magnet Cassette; Cochlear™ Non-Magnetic Cassette; Cochlear™ Osia® 2(I) Sound Processor; Cochlear™ Osia® Fitting Software 2; Cochlear™ Osia® Smart App (2023), cited by 1
- K240155: Cochlear Osia System (2024), cited by 1
- K183373: Bonebridge (2019), cited by 1

Source page: https://510kreport.com/product-code/PFO
Data by year (CSV): https://510kreport.com/product-code/PFO.csv