# ImpediMed Limited

- Location (FDA's records): Pinkenba, AU
- FDA decisions: 17 (2005–2026): 17 510(k) clearances
- Names in FDA's records: ImpediMed Limited (13); Impedimed Pty , Ltd. (4)
- Product codes: OBH (8), DSB (5), MNW (2), QJB (2)
- Predicates its devices cite: 21 (15 its own); citations of its devices by later devices: 19 (15 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Xitron Technologies, Inc.: 2 (https://510kreport.com/company/xitron-technologies)
- Bodystat, Ltd.: 2 (https://510kreport.com/company/bodystat)
- Intersection Medical, Inc.: 1 (https://510kreport.com/company/intersection-medical)
- Rjl Systems, Inc.: 1 (https://510kreport.com/company/rjl-systems)

## Firms that cite its devices most
- Delfin Technologies, Ltd.: 1 (https://510kreport.com/company/delfin-technologies)
- Ld Technology, LLC: 1 (https://510kreport.com/company/ld-technology)
- Rjl Systems, Inc.: 1 (https://510kreport.com/company/rjl-systems)
- Cerebrotech Medical Systems, Inc.: 1 (https://510kreport.com/company/cerebrotech-medical-systems)

## Its most-cited devices
- K172507: SOZO (2017), cited by 2
- K052319: Impedimed - Body Composition Analyzer, Model Imp SFB7 (2006), cited by 2
- K232089: SOZO Pro (2023), cited by 2
- K130338: Impedimed - Bis Extra Cellular Fluid Analysis (2013), cited by 2
- K080825: Impedimed Extra Cellular Fluid Analysis, Model L-Dex U400 (2008), cited by 2
- K050395: Impedimed - Body Composition Analysis (2005), cited by 2

## Recent decisions
- K260224: MySOZO Software version 6.1.0.1 (SW version 6.1.0.1) (Aug 17, 2026)
- K253224: MySOZO Software version 6.0.1.2 (SW version 6.0.1.2) (Jan 28, 2026)
- K232089: SOZO Pro (Oct 17, 2023)
- K230530: SOZO Pro (May 4, 2023)
- K230531: SOZO Pro (May 4, 2023)
- K203473: SOZO (Apr 19, 2021)
- K193410: SOZO Body Fluid Analyzer (Oct 2, 2020)
- K190529: SOZO (Nov 25, 2019)

Source page: https://510kreport.com/company/impedimed