Atlas FDA

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

Gme German Medical Engineering GmbH · Predicate Candidate Screening

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

146 daysmedian FDA review time
277 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nmGme German Medical Engineering GmbH2023-03-102770
K203054FlexSysGme German Medical Engineering GmbH2021-03-051490
K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH2019-11-19900
K180518GME LinScan Lite 808 Laser SystemGme German Medical Engineering GmbH2018-07-231460
K150752GME ExSys 308Gme (German Medical Engineering) GmbH2015-07-311300
K141063LINSCAN 808, LINSCAN 980Gme (German Medical Engineering) GmbH2014-07-15820

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