# Oticon Medical AB

- Location (FDA's records): Askim, SE
- FDA decisions: 18 (2008–2026): 17 510(k) clearances and 1 original PMA approval
- Names in FDA's records: Oticon Medical AB (17); Oticon Medical (1)
- Product codes: LXB (8), MAH (7), MCM (1), KCT (1), PFO (1)
- 510(k) review time since 2016: median 75 days, against 79 for FDA's reviews in the same codes and years (3 of 3 faster)
- Predicates its devices cite: 30 (21 its own); citations of its devices by later devices: 24 (21 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Cochlear Bone Anchored Systems AB: 3 (https://510kreport.com/company/cochlear-bone-anchored-systems)
- Entific Medical Systems, Inc.: 2 (https://510kreport.com/company/entific-medical-systems)
- Cochlear Americas: 1 (https://510kreport.com/company/cochlear-americas)
- Hu-Friedy Mfg. Co., Inc.: 1 (https://510kreport.com/company/hu-friedy-mfg)
- Symmetry Medical: 1 (https://510kreport.com/company/symmetry-medical)
- Med-El Elektromedizinische Geraete GmbH: 1 (https://510kreport.com/company/med-el-elektromedizinische-geraete)

## Firms that cite its devices most
- Paragon Medical: 1 (https://510kreport.com/company/paragon-medical)
- Sophono, Inc.: 1 (https://510kreport.com/company/sophono)
- Cochlear Americas: 1 (https://510kreport.com/company/cochlear-americas)

## Its most-cited devices
- K112053: Obc Bone Anchored Hearing System (2011), cited by 3
- K090996: Ponto Pro (2009), cited by 3
- K161671: Ponto 3, Ponto 3 Power and Ponto 3 SuperPower (2016), cited by 3
- K082108: Obc Bone Anchored Hearing Aid System (2008), cited by 2
- K121228: Ponto Bone Anchored Hearing System (2012), cited by 2
- K211640: Ponto 5 Mini (2021), cited by 2

## Recent decisions
- K261142: Ponto 5 Mini; Ponto 5 Superpower (Aug 26, 2026)
- K240614: Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS (Jul 10, 2024)
- K213733: Ponto 5 SuperPower (Dec 16, 2021)
- K211640: Ponto 5 Mini (Aug 10, 2021)
- P200021: Neuro Cochlear Implant System (Jun 23, 2021)
- K203807: Ponto Bone Anchored Hearing System, MONO Surgery Kit (Mar 3, 2021)
- K190540: Ponto 4 (May 2, 2019)
- K161671: Ponto 3, Ponto 3 Power and Ponto 3 SuperPower (Sep 29, 2016)

Source page: https://510kreport.com/company/oticon-medical