Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pulsion Medical Systems SE · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K192169 | PulsioFlex Monitoring System with ProAQT Sensor | Pulsion Medical Systems SE | 2020-04-30 | 265 | 0 |
| K171620 | PiCCO Catheter | Pulsion Medical Systems SE | 2018-02-21 | 264 | 0 |
| K172259 | PulsioFlex Monitoring System | Pulsion Medical Systems SE | 2018-01-18 | 175 | 0 |
| K122121 | PULSIOFLEX MONITORING SYSTEM WITH PICCO MODULE | Pulsion Medical Systems SE | 2012-08-02 | 16 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda