# Pulsion Medical Systems AG

- Location (FDA's records): Feldkirchen, DE
- FDA decisions: 12 (2000–2020): 12 510(k) clearances
- Names in FDA's records: Pulsion Medical Systems AG (5); Pulsion Medical Systems SE (4); Pulsion Medical Systems, Inc. (3)
- Product codes: DXG (8), KRB (4)
- Predicates its devices cite: 12 (5 its own); citations of its devices by later devices: 14 (5 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Edwards Lifesciences, LLC: 2 (https://510kreport.com/company/edwards-lifesciences)
- Utah Medical Products, Inc.: 2 (https://510kreport.com/company/utah-medical-products)
- American Edwards Laboratories: 1 (https://510kreport.com/company/american-edwards-laboratories)
- Arrow Intl., Inc.: 1 (https://510kreport.com/company/arrow-intl)
- Spectramed, Inc.: 1 (https://510kreport.com/company/spectramed)

## Firms that cite its devices most
- Edwards Lifesciences, LLC: 3 (https://510kreport.com/company/edwards-lifesciences)
- GE Healthcare Finland Oy: 1 (https://510kreport.com/company/ge-healthcare-finland)
- Mindray North America: 1 (https://510kreport.com/company/mindray-north-america)
- Applied Physiology Pty, Ltd.: 1 (https://510kreport.com/company/applied-physiology)
- Transonic Systems, Inc.: 1 (https://510kreport.com/company/transonic-systems)
- Draeger Medical Systems, Inc.: 1 (https://510kreport.com/company/draeger-medical-systems)
- Cnsystems Medizintechnik GmbH: 1 (https://510kreport.com/company/cnsystems-medizintechnik)

## Its most-cited devices
- K072735: Pulsion Picco-2, Model 8500 (2007), cited by 4
- K060898: Pulsion Picco Plus, Model 8100 (2006), cited by 3
- K172259: PulsioFlex Monitoring System (2018), cited by 2
- K072364: Pulsion Pulsiocath Thermodilution Catheters & Accessories (2007), cited by 2
- K091786: Pulsion PICCO2 (8500), Cevox Optical Module (PC3015), Cevox Disposable  Probes (PV2022-30 Thru -38, PV2022-46 Thru -48) (2010), cited by 1
- K122121: Pulsioflex Monitoring System with Picco Module (2012), cited by 1

## Recent decisions
- K192169: PulsioFlex Monitoring System with ProAQT Sensor (Apr 30, 2020)
- K171620: PiCCO Catheter (Feb 21, 2018)
- K172259: PulsioFlex Monitoring System (Jan 18, 2018)
- K122121: Pulsioflex Monitoring System with Picco Module (Aug 2, 2012)
- K112448: Pulsioflex (Sep 22, 2011)
- K091786: Pulsion PICCO2 (8500), Cevox Optical Module (PC3015), Cevox Disposable  Probes (PV2022-30 Thru -38, PV2022-46 Thru -48) (Jun 18, 2010)
- K072735: Pulsion Picco-2, Model 8500 (Oct 18, 2007)
- K072364: Pulsion Pulsiocath Thermodilution Catheters & Accessories (Sep 19, 2007)

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