Atlas FDA

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

Oehm Und Rehbein GmbH · Predicate Candidate Screening

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

88 daysmedian FDA review time
217 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K182317AMADEO M-DR mini, AMADEO M-AX miniOehm Und Rehbein GmbH2018-09-24280
K141440DICOMPACS DX-R WITH FLAT PANELOehm Und Rehbein GmbH2014-08-29880
K131211DICOMPACS DX-R WITH FLAT PANELOehm Und Rehbein GmbH2013-11-051900
K091364DICOMPACS, MODEL 5.2, DICOMPACS DX-R, MODEL 1.4Oehm Und Rehbein GmbH2009-12-112170
K070618DICOMPACS, MODEL 5Oehm Und Rehbein GmbH2007-04-25510

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