Atlas FDA

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

Boehringer Laboratories, LLC — Predicate Candidate Screening

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

86 daysmedian FDA review time
244 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K243399Boehringer Laboratories Liver RetractorBoehringer Laboratories, LLC2025-07-022440
K234033ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340)Boehringer Laboratories, LLC2024-05-061380
K151990Tissue Removal SystemBoehringer Laboratories, LLC2015-09-11530
K150781Tissue Removal PouchBoehringer Laboratories, LLC2015-06-19860
K130483BOEHRINGER GASTRIC SIZING TUBEBoehringer Laboratories, LLC2013-03-28310

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