# Bionix Development Corp.

- Location (FDA's records): Toledo, OH
- FDA decisions: 13 (1990–2018): 13 510(k) clearances
- Names in FDA's records: Bionix Development Corp. (12); Bionix Development Corporation (1)
- Product codes: IYE (10), KNT (1), PDH (1), HFX (1)
- Predicates its devices cite: 22 (1 its own); citations of its devices by later devices: 14 (1 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
- Medtec, Inc.: 8 (https://510kreport.com/company/medtec)
- Wfr/Aquaplast Corp.: 2 (https://510kreport.com/company/wfr-aquaplast)
- Actuated Medical, Inc.: 1 (https://510kreport.com/company/actuated-medical)
- Nova Design Technologies, Ltd.: 1 (https://510kreport.com/company/nova-design-technologies)
- Medical Intelligence Medizintechnik GmbH: 1 (https://510kreport.com/company/medical-intelligence-medizintechnik)
- Medical Instrumentation & Diagnostics Corp.(Midco): 1 (https://510kreport.com/company/medical-instrumentation-diagnostics-midco)
- Larson Products, Inc.: 1 (https://510kreport.com/company/larson-products)
- Radionics Software Applications, Inc.: 1 (https://510kreport.com/company/radionics-software-applications)

## Firms that cite its devices most
- Cdr Systems, Inc.: 4 (https://510kreport.com/company/cdr-systems)
- Sinmed BV: 2 (https://510kreport.com/company/sinmed)
- Aktina Medical Corporation: 1 (https://510kreport.com/company/aktina-medical)
- Salter Labs: 1 (https://510kreport.com/company/salter-labs)
- Orfit Industries NV: 1 (https://510kreport.com/company/orfit-industries)
- Radtec Medical Devices, Inc.: 1 (https://510kreport.com/company/radtec-medical-devices)
- Blessing Cathay Corporation: 1 (https://510kreport.com/company/blessing-cathay)
- Poll Medical, LLC: 1 (https://510kreport.com/company/poll-medical)

## Its most-cited devices
- K040773: Pelvis Bellyboard Plus Patient Positioning System (2004), cited by 3
- K120335: Embrace Thermoplastic (2012), cited by 2
- K153270: TruGuard Custom Tongue and Jaw Positioner (2016), cited by 2
- K030051: Versaboard, Model 7040 (2003), cited by 2
- K050701: Thigh and Foot Positioner, Suprone Plus, Model RT-6010 (2005), cited by 1
- K100691: Omni V SBRT Positioning System, Model RT-4500 (2010), cited by 1

## Recent decisions
- K180605: GastroFlush (Oct 24, 2018)
- K153270: TruGuard Custom Tongue and Jaw Positioner (Mar 8, 2016)
- K123411: Little Angels Swaddling Blanket (Mar 7, 2013)
- K120335: Embrace Thermoplastic (May 3, 2012)
- K100691: Omni V SBRT Positioning System, Model RT-4500 (May 11, 2010)
- K100264: T-Form Extremity Immobilizer, Model RT-6060 (Apr 9, 2010)
- K050701: Thigh and Foot Positioner, Suprone Plus, Model RT-6010 (Apr 1, 2005)
- K040773: Pelvis Bellyboard Plus Patient Positioning System (Apr 9, 2004)

Source page: https://510kreport.com/company/bionix-development