Atlas FDA

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

Medcom GmbH — Predicate Candidate Screening

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

90 daysmedian FDA review time
127 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K181789VeriSuiteMedcom GmbH2018-09-21780
K180308PreludeMedcom GmbH2018-03-27530
K170841BiopSee, Mobile USMedcom GmbH2017-07-261270
K163119NaviSuite SSI EditionMedcom GmbH2017-05-011740
K133914VERISUITE 1.8, VERISUITE-PARTICLE 1.8, VERISUITE, VERISUITE-Medcom GmbH2014-04-031010
K102237PVS MODEL 1.0Medcom GmbH2010-11-231060
K100056MEDCOM RT-VIEWER SYSTEMMedcom GmbH2010-05-071190
K092653VERISUITE AND VERISUITE-PARTICLE, VERSION 1.8Medcom GmbH2009-09-18210
K080742VERISUITE 1.6, VERISUITE-PARTICLE 1.6Medcom GmbH2008-05-09530
K032550EXOMIO, MODEL 2.0 SP1Medcom GmbH2003-09-25380
K022219EXOMIO, MODEL 1.1Medcom GmbH2002-10-07900

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