Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Pulsion Medical Systems AG · Predicate Candidate Screening

5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

90 daysmedian FDA review time
366 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K091786PULSION PICCO2 (8500), CEVOX OPTICAL MODULE (PC3015), CEVOX Pulsion Medical Systems AG2010-06-183660
K072735PULSION PICCO-2, MODEL 8500Pulsion Medical Systems AG2007-10-18210
K072364PULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIESPulsion Medical Systems AG2007-09-19280
K060898PULSION PICCO PLUS, MODEL 8100Pulsion Medical Systems AG2006-07-251130
K020587PULSION PULSIOCATH PICCO MONITORING KIT, INJECTATE SENSOR TEPulsion Medical Systems AG2002-05-23900

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