510(k) Report

FDA applicant

Pulsion Medical Systems AG

Feldkirchen, DE12 decisions2000–20202 recalls

FDA records 12 decisions for Pulsion Medical Systems AG (Feldkirchen, DE) from 2000 to 2020: 12 510(k) clearances. Most are in product codes DXG (Computer, Diagnostic, Pre-Programmed…) and KRB (Probe, Thermodilution). Its devices cite 12 predicates, 5 of them its own earlier devices. 2 recalls are linked to its devices.

FDA’s records also spell it “Pulsion Medical Systems SE”, “Pulsion Medical Systems, Inc.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Pulsion Medical Systems AG’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2007: 22010: 12011: 12012: 12018: 22020: 1
2007high 2 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2019

2014: 12019: 1
2007high 1 (2014) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Pulsion Medical Systems AG by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Pulsion Medical Systems AG’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • DXGComputer, Diagnostic, Pre-Programmed, Single-Function8decisions
  • KRBProbe, Thermodilution4decisions

Whose devices does it build on?

Its devices cite 12 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 14 times; 5 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K072735Pulsion Picco-2, Model 8500Pulsion Medical Systems AG · 20074cite it
  • K060898Pulsion Picco Plus, Model 8100Pulsion Medical Systems AG · 20063cite it
  • K172259PulsioFlex Monitoring SystemPulsion Medical Systems SE · 20182cite it
  • K072364Pulsion Pulsiocath Thermodilution Catheters & AccessoriesPulsion Medical Systems AG · 20072cite it
  • K091786Pulsion PICCO2 (8500), Cevox Optical Module (PC3015), Cevox Disposable Probes (PV2022-30 Thru -38, PV2022-46…Pulsion Medical Systems AG · 20101cites it
  • K122121Pulsioflex Monitoring System with Picco ModulePulsion Medical Systems SE · 20121cites it

What has FDA decided for it lately?

  • K192169PulsioFlex Monitoring System with ProAQT SensorPulsion Medical Systems SE · 2020
  • K171620PiCCO CatheterPulsion Medical Systems SE · 2018
  • K172259PulsioFlex Monitoring SystemPulsion Medical Systems SE · 20181 recall
  • K122121Pulsioflex Monitoring System with Picco ModulePulsion Medical Systems SE · 2012
  • K112448PulsioflexPulsion Medical Systems, Inc. · 2011
  • K091786Pulsion PICCO2 (8500), Cevox Optical Module (PC3015), Cevox Disposable Probes (PV2022-30 Thru -38, PV2022-46…Pulsion Medical Systems AG · 2010
  • K072735Pulsion Picco-2, Model 8500Pulsion Medical Systems AG · 2007
  • K072364Pulsion Pulsiocath Thermodilution Catheters & AccessoriesPulsion Medical Systems AG · 2007

All 5 as Pulsion Medical Systems AG →All 4 as Pulsion Medical Systems SE →All 3 as Pulsion Medical Systems, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K172259PulsioFlex Monitoring System, Part Number: 6882747, Model Number: PC400 3 R0. Usage: The…Jun 5, 2019Class II
  • K991886Pulsiocath PiCCO ProAQT Monitoring Kit, single-use cardiac output (CO) sensor, one unit…Nov 4, 2014Class II