Pulsion Medical Systems AG: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Pulsion Medical Systems AG” (first 2002, latest 2010), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 90 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Getinge, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | 3 | 3 |
| KRB | Probe, Thermodilution | 2 | 2 |
Review panels
- Cardiovascular (5)
Most recent Pulsion Medical Systems AG 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K091786 | PULSION PICCO2 (8500), CEVOX OPTICAL MODULE (PC3015), CEVOX DISPOSABLE PROBES (PV2022-30 THRU -38, PV2022-46 THRU -48) | DXG | 2010-06-18 | 366 |
| K072735 | PULSION PICCO-2, MODEL 8500 | DXG | 2007-10-18 | 21 |
| K072364 | PULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIES | KRB | 2007-09-19 | 28 |
| K060898 | PULSION PICCO PLUS, MODEL 8100 | DXG | 2006-07-25 | 113 |
| K020587 | PULSION PULSIOCATH PICCO MONITORING KIT, INJECTATE SENSOR TEMPERATURE HOUSING PV 4046 | KRB | 2002-05-23 | 90 |
Recalls
openFDA lists no recalls under a recalling firm named Pulsion Medical Systems AG.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Pulsion Medical Systems SE (4 510(k)s)
- Pulsion Medical Systems, Inc. (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Pulsion Medical Systems AG?
FDA lists 5 510(k) clearances under the applicant name “Pulsion Medical Systems AG” (first 2002, latest 2010), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Pulsion Medical Systems AG?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pulsion Medical Systems AG is 90 days.
Which FDA product codes appear under Pulsion Medical Systems AG?
The most frequent FDA product codes under this applicant name are DXG (Computer, Diagnostic, Pre-Programmed, Single-Function, 3); KRB (Probe, Thermodilution, 2).
Next steps
- See all 5 Pulsion Medical Systems AG clearances with predicates and recalls
- Run predicate analysis for product code DXG, Pulsion Medical Systems AG's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.