Atlas FDA

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

Geister Medizin Technik GmbH · Predicate Candidate Screening

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

267 daysmedian FDA review time
675 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K242759Geister K-Rex rongeursGeister Medizin Technik GmbH2025-06-062670
K180610Geister retractor for neuro - and spine surgeryGeister Medizin Technik GmbH2018-08-291740
K022823VALVULOTOME, RETROGRADE : 03-7500- 03-7510, ANTEGRADE 03-752Geister Medizin Technik GmbH2004-07-016750
K030788KAMAR ANNULUS DILATOR + SIZER; GARRETT, COOLEY, AND DEBAKEY Geister Medizin Technik GmbH2003-07-121220
K982365ATRAUMATIC VASCULAR CLAMPS, MODEL #'S 22-XXXX, 23-XXXX, 03-6Geister Medizin Technik GmbH1999-04-082750
K933699GEISTER SURGICAL INT'L BIPOLAR ENDOSCOPIC SURGICAL INSTRUMENGeister Medizin Technik GmbH1994-01-271820

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