# Simex Medizintechnik GmbH

- Location (FDA's records): Deisslingen, DE
- FDA decisions: 3 (2012–2016): 3 510(k) clearances
- Product codes: OMP (2), BTA (1)
- Predicates its devices cite: 9 (1 its own); citations of its devices by later devices: 2 (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
- Novaspine, LLC: 2 (https://510kreport.com/company/novaspine)
- Medela AG: 2 (https://510kreport.com/company/medela)
- Blue Ocean Medical Product, LLC: 1 (https://510kreport.com/company/blue-ocean-medical-product)
- Medica-Rents Co., Ltd.: 1 (https://510kreport.com/company/medica-rents)
- Kinetic Concepts, Inc.: 1 (https://510kreport.com/company/kinetic-concepts)
- Blue Sky Medical Group Incorporated: 1 (https://510kreport.com/company/blue-sky-medical-group)

## Firms that cite its devices most
- Hospitech Respiration, Ltd.: 1 (https://510kreport.com/company/hospitech-respiration)

## Its most-cited devices
- K113291: Simex Negative Pressure Wound Therapy Powered Suction Pumps Series: Sim-EX200 and Sim-EX300 (2012), cited by 1
- K141255: Simex Subglottic Aspiration System (2014), cited by 1

## Recent decisions
- K150459: FloSure Ventilation Patch (Jan 5, 2016)
- K141255: Simex Subglottic Aspiration System (Sep 22, 2014)
- K113291: Simex Negative Pressure Wound Therapy Powered Suction Pumps Series: Sim-EX200 and Sim-EX300 (Aug 30, 2012)

Source page: https://510kreport.com/company/simex-medizintechnik