Atlas FDA

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

Jk-Holding GmbH — Predicate Candidate Screening

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

113 daysmedian FDA review time
224 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K220500Ergoline Vitality Total Light 3, Planet Fitness 50/4 TLT by Jk-Holding GmbH2022-07-011290
K190173Ergoline Inspiration 550 Hybrid Technology / Sound, ErgolineJk-Holding GmbH2019-05-10980
K183539Ergoline Sunrise 7200 Hybrid TechnologyJk-Holding GmbH2019-04-081090
K180555Ergoline Prestige 1600 Hybrid PerformanceJk Holding GmbH2018-10-112240
K173565Sunrise 6200, Sunrise 7200Jk-Holding GmbH2018-02-14890
K151400Ergoline, Sun Angel, Soltron, Sundash and Palm Beach Tan SunJk Holding GmbH2015-09-161130

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