Atlas FDA

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

I.E.M. GmbH — Predicate Candidate Screening

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

157 daysmedian FDA review time
288 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K153557ABPM 7100, Hypertension Management SoftwareI.E.M. GmbH2016-07-192180
K140928ABPM7100I.E.M. GmbH2014-09-151570
K110603HYPERTENSION MANAGEMENT SOFTWARE CLAIENT SERVER (HMS-CS)I.E.M. GmbH2011-12-162880
K072446MOBIL-O-GRAPH NG 24 H ABP-CONTROLI.E.M. GmbH2007-11-29910
K041313STABIL-O-GRAPHI.E.M. GmbH2004-06-18320

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