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Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Getemed Medizin- Und Informationstechnik AG · Predicate Candidate Screening

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

177 daysmedian FDA review time
245 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K162023CardioDay V2.5Getemed Medizin- Und Informationstechnik AG2017-03-242450
K130516CARDIODAYGetemed Medizin- Und Informationstechnik AG2013-08-231770
K130785SEER 1000Getemed Medizin- Und Informationstechnik AG2013-07-261270
K122272CARDIOMEMGetemed Medizin- Und Informationstechnik AG2013-03-282410
K063042CARDIOMEM CM 3000-12BTGetemed Medizin- Und Informationstechnik AG2007-05-302390
K070280CARDIODAY, VERSION 2.0Getemed Medizin- Und Informationstechnik AG2007-02-23250
K051686CARDIOMEM CM 3000-12Getemed Medizin- Und Informationstechnik AG2005-07-14210
K051471CARDIODAYGetemed Medizin- Und Informationstechnik AG2005-06-29260

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