Atlas FDA

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

Dornier Medtech America — Predicate Candidate Screening

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

76 daysmedian FDA review time
268 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K243820Hoover Negative Pressure Access Sheath (Hoover) (Hoover ModeDornier Medtech America2025-01-31500
K233380TRIDENT Mobile Fluoroscopy SystemDornier Medtech America2024-06-262680
K180350Dornier Medilas H Solvo 35 LaserDornier Medtech America2018-03-07270
K170122Delta III LithotripterDornier Medtech America2017-06-281660
K151298Gemini XXP-HPDornier Medtech America2015-07-30760
K132672EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTERDornier Medtech America2013-09-23270

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