Atlas FDA

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

Raumedic AG — Predicate Candidate Screening

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

123 daysmedian FDA review time
238 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K250285NEUROVENT-P (092946-003); NEUROVENT (092956-003); NEUROVENT-Raumedic AG2025-08-292100
K171666MPR2 logO DATALOGGERRaumedic AG2017-07-06310
K130529RAUMEDIC-PTO-MONITORING-SYSTEMRaumedic AG2013-10-252380
K120252RAUMEDIC-ICP-TEMP-MONITORING-SYSTEMRaumedic AG2012-04-11750
K112017RAUMEDIC ICP MONITORING SYSTEMRaumedic AG2011-10-11890
K103206RAUMEDIC- ICP-MONITORING SYSTEMRaumedic AG2011-03-041230

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