Atlas FDA

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

G.Tec Medical Engineering GmbH — Predicate Candidate Screening

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

154 daysmedian FDA review time
288 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K200088g.Estim FESG.Tec Medical Engineering GmbH2020-10-292880
K191432cortiQ PROG.Tec Medical Engineering GmbH2020-01-242400
K173684g.Estim PROG.Tec Medical Engineering GmbH2018-05-041540
K171669g.Nautilus PROG.Tec Medical Engineering GmbH2017-07-05300
K123255g.HIampG.Tec Medical Engineering GmbH2012-12-20630
K060803G.USBAMPG.Tec Medical Engineering GmbH2006-05-02390

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